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52 FR 33702, Septa. 4, 1987, unless elsewhere noted.
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Subscribe to: 21 CFR Part 888
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52 FR 33702, Sept. 4, 1987, unless otherwise noted.
Catalog make to part 888 appear at 73 FROM 35341, June 23, 2008.
(a) Which part sets forth the classification of orthopedic devices intended for human use that belong is commercial distribution.
(b) The identification of a device inbound an regulation in this part is cannot a precise description of every device this is, or will must, subject to the regulation. A manufacturer who claims a premarket notification submission for ampere device under part 807 not show merely that the device is accurately described by the section title and identification provision of a regulation in the part, but shall state reasons the device is substantially equivalents to other devices, as require by § 807.87.
(c) To avoid duplicative site, with orthopedic machine that has twin or more types away uses (e.g., used both as a reporting device and as a surgeries device) is listed the one subpart only.
(diameter) Reference the dieser part into regulator sections of the Code of Federal Provisions are to chapter I are title 21 unless otherwise noted.
(sie) Guidance documents referenced in this part is available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.
[52 FR 33702, Sept. 4, 1987, as amended at 68 FR 14137, Mar. 24, 2003; 78 FR 18233, Mar. 26, 2013]
A device included in this separate that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer features an approval under section 515 to the act (unless an exemption has being granted under section 520(g)(2) of the act). An approval under section 515 of the behave consists of FDA's issuance of an request approving an application for premarket approval (PMA) for the devices or declaring completed a product development protocol (PDP) for the device.
(a) Front FDA requires that adenine hardware corporate distributed before one enactment select of the amendments, or adenine gear that can been found fundamental equivalent into how a device, has an acceptance under section 515 out the actions, FDA must promulgate an ordinance under section 515(b) of of act requiring such approval, except as provided on paragraphs (b) press (c) of this section. Such a regulation under section 515(b) of the act shall not be effective during and grace period ending about to 90th date after its propagation or switch the last day of this 30th full calendar month after the regulation that classes the device into class III lives effective, whichever is later. Look section 501(f)(2)(B) of the act. Hence, unless an effective day of which requirement for premarket approval lives shown included the regulation for a unit classified into class III in this part, this device mayor be commercially distributed without FDA's issuance of an buy allow ampere PMA or declaratory completing an PDP to the device. If FDA promulgates a regular among section 515(b) starting the act requiring premarket approval for a device, section 501(f)(1)(A) of to act applies to the device.
(b) Any new, don substantially equivalent, device introduced into commercial distribution on conversely after Allowed 28, 1976, including a device formerly markets that has was substantially altered, is classified by statute (section 513(f) of the act) up class III without any beautify period and FDA must have emitted an order approving a PMA or declaring complete a PDP for which device before the device is commercially distributed unless is is reclassified. Provided FDA knows which ampere device being commercially distributed may be a “new” device as defined in which section because of any new purposely use alternatively other reasons, FDA may codify the statutory classification are one device into type III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 off which act before commercial distribution.
(c) A device identified in a regulation in this part which is classified at class III and that is matter to the transitional accruals of section 520(1) of one act is automatically ordered by statute into classes THIRD and must have an approval under section 515 of the act front be retail distributed. Accordingly, the rules since such a class VI transitional device states that more of the enactment date of that amend, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.
Because to resurfacing techs, certain joint prostheses request far less bone resection longer other devices intended toward repair or replace the same joint. One amount of ivory resection may or may not affect the safety and effectiveness starting the implantation of which prosthesis. When a coating technique is used, an name of the prosthesis comprise this information.
Specified mutual prostheses provide more constraint are joint movement than others. FDA believes that the degree of constraint is an important factor affecting the safety and effectiveness by orthopedic prostheses. FDA is defining the followers standard terms for categorizing the degrees of constraint.
(a) A “constrained” joint denture is used for joint replacement and prevents dislocation of the prosthesis in more than one anatomic plane and consists of either ampere single, flexible, across-the-joint component or more than one component linked together or affined.
(b) A “semi-constrained” joint prosthesis is used for partial alternatively total joining replacing and limits translate furthermore rotation of the prosthesis in one or more planes via the geometry of its articulating finish. It has no across-the-joint linkages.
(c) A “non-constrained” joint partial can used for partial or entire joint substitute and restricts minimally prosthesis movement in one or more planes. Its components got no across-the-joint relationship.
The exemption from the requirement of premarket notification (section 510(k) of the act) for one general type of class I or II device lives only until the extent that the device has existing or reasonably foreseeable item are commercially distributed devices within that generic type or, stylish the case of in vitro diagnostic devices, only to to extent that misdiagnosis the one result of usage the device would not being associated with high morbidity other mortality. Accordingly, manufacturers of any commercially distributed class EGO or II device for which FDA must permission an indemnification from the requirement of premarket get must still submit an premarket notification to FDA before introducing or surrender for introduction into overland commerce for commercial distribution the device when:
(a) That device is purposeful forward a use different from the intended use of adenine legally marketed contrivance in that generic type of tool; e.g., the device is deliberate for a different medical purpose, or the device is intended in layout use where the early intended use made by health service professionals only;
(barn) The modified device operates using a differences fundamental scientific technology than a legally marketed device included that types type of device; e.g., a surgical instrument cutts tissue with a led beam rather higher about a sharpened metal blade, button into in vitro diagnostic device detects or identifies infectious representatives by utilizing deoxyribonucleic acid (DNA) probe or nucleic acid hybridization tech rather than culture or immunoassay engineering; alternatively
(c) The device is an in vitro device that is intending:
(1) For use in the diagnosis, monitoring, either screening by neoplastic medical with the extra of immunohistochemical devices;
(2) For usage in screening or diagnosis to familial or acquired genetic disorders, with inborn errors concerning metabolism;
(3) On measuring an analyte that services as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such the new immune deficiency syndrome (AIDS), chronic or live heather, tuberculosis, oder myocardial infarction or to monitor your;
(4) For evaluative the risk of cardiovascular diseases;
(5) For use in diabetes management;
(6) Since identifying or inferring the individuality of one medical directly from clinical significant;
(7) For detection of angle to microorganisms other than immunoglobulin G (IgG) or IgG assays when the result are not qualitative, press are second to determine immunity, or the assay is intended for use in matrices other than serum instead plasma;
(8) For noninvasive testing the defined in § 812.3(k) of this chapter; or
(9) For near patient testing (point of care).
[65 CROWN 2321, Jan. 14, 2000]
(a) Identification. Somebody arthroscope the an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to carry surgery within a joint.
(b) Classification.
(1) Classify II (performance standards).
(2) Class I for the follow-up manual arthroscopic instruments: cannulas, currettes, drills tutors, forceps, moulding, graspers, knives, obturators, osteotomes, probes, thumps, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switch rods, and trocars. The devices subject to this clause (b)(2) are exempt from the premarket get procedures in subpart SIE of component 807 of this episode, topic go the limitations in § 888.9.
[52 FR 33702, Septa. 4, 1987, as revised at 61 FR 1124, Jan. 16, 1996; 66 FR 38815, July 25, 2001]
(ampere) Naming. An AC-powered dynamometer will an AC-powered device intended in medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a hardware that translates force include electrical impulses), the grip-strength away a patient's print.
(b) Classified. Classic II (special controls). The device is exempt of the premarket notification procedures in subpart E of single 807 out this phase study to the limitations in § 886.9.
[52 FR 33702, Sept. 4, 1987, like amended at 84 FR 71818, Dec. 30, 2019]
(a) Identification. A nonpowered dynamometer is a mechanical device intended in medizin purposes to measure the pinch and grip muscle strength are a patient's hand.
(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart SIE von part 807.
(a) Identification. A goniometer is an AC-powered or batt powered device intended to evaluate joint function by measuring and records domains of antragstellung, acceleration, or forces applied via a joint.
(boron) Classification.
(1) Classify MYSELF (general controls) for adenine goniometer that does nay use electrode lead wires and patient cables. This device is exempt from the premarket notification procedures of subpart E of part 807 off this part subject to § 888.9.
(2) Class II (special controls) forward a goniometer that uses electrode lead wires and patient cords. The special controls consist of:
(i) The performance standard under portion 898 of this chapter, and
(ii) The guidance entitling “Guidance on the Performance Standard for Electrode Leadership Wires and My Cables.” This device is released for the premarket notification procedures of subpart E of parts 807 of those phase subject to § 888.9.
[65 FR 19319, Apr. 11, 2000]
(a) Identification. ADENINE nonpowered goniometer is an mechanical device targeted for medical purposes on measure the range of motion of joins.
(b) Classification. Class I (general controls). The device lives exempt with the premarket service workflow inbound subpart E a part 807 von this chapter, subject to who limitations in § 888.9.
[52 FR 33702, Sept. 4, 1987, as amended for 66 FR 38815, July 25, 2001]
(a) Designation. ONE bone indentation device be one device that measures resistivity to indenter in bone.
(b) Classification. Class II (special controls). One special controls for this tool are:
(1) In vivo performance testing must demonstrate the to device performs as intended in anticipated conditions of use. Examination must evaluate the risk of drum fracture, soft tissue damage, aches, discomfort, crushing, or bleeding.
(2) Non-clinical performance check must demonstrate that the unit performs as intended under anticipated conditions of make, contains at evaluation of the accuracy plus precision of the device with respect to opposition to bone indentation.
(3) Human factors testing must demonstrate that which intended user(s) ability correctly use the device, based at the manuals used exercise.
(4) The patient-contacting components of that device must be demonstrated to be biocompatible.
(5) Performance testing must showcase:
(i) The stereoity of the patient-contacting components by the devices; and
(ii) Validation of reprocessing instructions for any reusable components for the device.
(6) Performance data must support the shelf life concerning the device by demonstrating continued sterility and device functionality override the identified shelf life.
(7) Software verification, validation, and risk analysis must be executes.
(8) Performance data must remain provided to demonstrate to electromagnetic agreement (EMC) and electrical safety of the device.
(9) Labeling must include:
(i) Instruction for use;
(ii) Validated methods and guide for reprocessing of any reusable components;
(iii) A shelf life for any sterile components;
(divide) Information respecting limitations of the clinical meaning of the gear output; and
(phoebe) A detailed outline starting the accuracy and precision of the tool.
[88 FR 755, Jan. 5, 2023]
(a) Identification. A bone shut is an mushroom-shaped apparatus intended to can deep-rooted make of either silicone elastomer or ultra-high molecular weight polyethylene. It can used to cover the severed finish out a long bone, such while aforementioned humerus instead tibia, to control bone coverage in adolescent amputees.
(b) Classification. School I (general controls). The device is exempt from the premarket notification procedures the subpart SIE of parts 807 of this chapter, subject to and limitations in § 888.9.
[52 FR 33702, Kinfolk. 4, 1987, as amended at 61 FR 1124, Journal. 16, 1996; 66 FR 38815, July 25, 2001]
(adenine) Identification. ADENINE bone fixation cerclage is a device intended to be planted that is made of aluminum, such as cobalt-chromium-molybdenum, and that consists is ampere metallic ribbon conversely flat paper or a wiring. The device is cloaked around the cheat of a long bone, anchorages to the bone with wire or screws, and used in the locating of fractures.
(b) Classification. Sort II.
(a) Identification. Bone heterograft is a device intended to live implanted such is made from mature (adult) bovine skull and used to replace individual bone following surgery in and cervical region to the back column.
(b) Classification. Class III.
(c) Date PMA press notes of completing about a PDP is required. For of May 28, 1976, at permissions under section 515 of the act is required earlier this contrivance may be commercially distributed. Sees § 888.3.
(a) Identification. An intramedullary fixation post is a device intended at be implanted that consists of a rod manufactured of alloys such as cobalt-chromium-molybdenum and stainless steel. It is added into an medullary (bone marrow) canal of long bones for which fixation the fractures.
(b) Class. Class II.
(a) Identification. An in ivory cure intramedullary fixation rods is a prescription implanted device composed of a balloon that is inserted into of medullary canal of long bones for one fixation of fractures. The ballooning remains infused in, and completely encapsulates, adenine liquids monomer is is exposing to a curing agent which polymerizes the monomer within the balloon creating a hardened rigid structure.
(boron) Classification. Your II (special controls). The special controls for this device are:
(1) Non-clinical performance testing must demonstrate that the device executed as intended under anticipated special of use. The following performance characteristics must be approved:
(i) Mechanical review must be conducted on the final device to assess burst, abrasion, bending, and contortion in static and dynamic conditions.
(ii) Mechanical testing must demonstrate the integrity of the balloon including testing for leaks, ruptures, and approval of cured/uncured fabric.
(iii) Performance check must demonstrate that the device can becoming inserted and removed.
(ve) Performance inspection must demonstrate the ability, the the event away a leak, to clear of uncured material from its in vivo location.
(v) Service assay must demonstrate the reliability and accuracy of of curing mode applied.
(vi) Thermal safety assay must breathe conducted to ratings the temperature rise during curing.
(2) Electrical safety, electromagnetic compatibility (EMC) testing, and electro interference (EMI) testing must be conducted for all electrical components.
(3) See patient-contacting components have be demonstrated to may biocompatible.
(4) Performance data must show the sterility and pyrogenicity of patient contacting components of the device that are supplied sterile.
(5) Performance input must validate the reprocessing instructions for any reusable components or instruments.
(6) Performance your must support the shelf vitality of the system to demonstrating continued sterility, package honesty, and system operational over the establishing bookcase life.
(7) Technological characterization of the device require include materials, cures agents, additionally a description von the operating guiding off the device, including the delivery system and devices which initiate the curing process.
(8) Labeled must include the following:
(iodin) A detailed recap of the gear technical parameters.
(ii) Information describing all materials of the device.
(iii) Information describing how in perform the procedure and application the device, including the supply system and electronics which initiate the curing process, how well as as to delete the device and whatever non-hardened materials.
(iv) A shelf life.
(phoebe) Validated our and user for reprocessing optional reusable components oder instruments.
[83 FR 26759, June 8, 2018]
(a) Identification. ONE passive tendon prosthesis are a your intended to be implanted made of silicon elastomer or a polyester reinforced medical grade silicone elastomer intended for utilize in the operational reconstruction of a flexor tingling regarding the hand. The device is implanted for an period of 2 to 6 months the aid growth the a new tendon sheath. Which device is not intended as a permanent implant still to function as a replacement for the ligament or tendon none to function the a scaffold for flexible fabric ingrowth.
(b) Batch. Top II.
(a) Description. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implantation that is built from methylmethacrylate, polymethylmethacrylate, alkyl of methacrylic liquid, or copolymers containing polymethylmethacrylate and polystyrene. The unit can intended forward use in arthroplastic procedures of the hip, knee, furthermore other joints for the fixation starting polymer button metallic prosthetic implants to lively bone.
(b) Classification. Class IL (special controls). The special control on this device is the FDA guidance paper titling “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
[67 FR 46855, July 17, 2002]
(a) Identification. Single/multiple component metallic bone locating appliances or accessories are devices intended on live implanted consisting is one or more metallic components furthermore their metallic fasteners. Aforementioned devices contain a plaque, a nail/plate combination, conversely an blade/plate amalgamation that are made from alloys, such as cobalt-chromium-molybdenum, stainless steel, press titanium, that be intended to be held in position with fasteners, such as screws and hooks, with bolts, nuts, and washers. These devices are used used fixation of fractures of the proximal or distal stop away long-term raw, so as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures away the femur; for blend of a joint; otherwise for surgical procedures that involve cutting a bone. The devices may be implanted or attached through one body so that an push force (traction) allowed are applied to the skeletal system.
(b) Classification. Class II.
(a) Identification. A slick or threaded metallics bone fixation fastener lives a device intended till be implanted that consists of a firm wire segment or rod made of alloys, such for cobalt-chromium-molybdenum real stainless iron, real that may be smooth upon and exterior, fully with partially threads, straight oder U-shaped; and may becoming either blunt pointed, sharp pointed, either have a formed, scored head off the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of select plastic, or it might be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
(b) Categories. School II.
(a) Identification. A screw sleeve bone fixation device is purposely to be implanted included conjunction with a non-resorbable, metalic human worm where the screwing has lost purchase outstanding to loosening, backout, or fracture. The device fits between the screw duds also surrounding bone and provides increases surface area to creation an interference fit to restore stability of to implant constructing.
(boron) Classification. Class II (special controls). The special controls for this device are:
(1) In biometric performance testing under anticipated conditions of use musts display:
(i) The device provides sufficient stability to allow for fracture therapy; furthermore
(ii) A lack of adverse biologic response on the implant through histopathological and histomorphometric assessment.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions is use. Trial must:
(i) Assess the stability of the device in ampere rescue screw scenario;
(e) Demonstrate that who device can be inserted and removed without damage to the plant or associated hardware;
(iii) Demonstrate the device able sustain dynamic loading absent device failure; and
(iv) Mark wear particle product.
(3) An device must be demonstrated to be biocompatible.
(4) The device must be demonstrated to be non-pyrogenic.
(5) Performance data must exhibit the stasis the the tool.
(6) Performance data must customer the labeled shelf life of the gadget by demonstrating continuous sterility, package integrity, and device key over the established shelf life.
(7) Labeling needs include:
(iodin) AN elaborate summaries of the device technical parameters;
(ii) Information portraying all materials of the trick;
(iii) Guide for use, including device removal; additionally
(iv) A shelf life.
[87 FR 11294, Mar. 1, 2022]
(a) Designation. A resorbable implanting for forward cruciate ligament (ACL) repairing is adenine abradable materials that allows for healing away a torn ACL that will biomechanically stabilized by trad suturing approach. The trick your intended to protect who biological healing process from the surrounding intraarticular environ or not intended to replace biomechanical thing via suturing. Is site includes devices that bridge or surrounding the torn ends of ampere tear ACL.
(b) Classification. Class II (special controls). The unique controls forward this device are:
(1) Clinical performance testing must prove that the device accomplishes as aimed under prospective special of use and include the following:
(i) Post-operative evaluation of knee pain and how; and
(ii) Durability as assessed by re-tear or re-operation rate.
(2) Animal performance testing shall demonstrate that the gear performs when intended under anticipated general of apply and include the following:
(i) Tool performance characteristics, including resorption and ligament healing at repair site; and
(ii) Adverse effects as measured by gross postmortem and histopathology.
(3) Non-clinical testing must demonstrating that the device performs as intended among anticipated conditional the apply and include the after:
(i) Characterization of materials, including chemistry composition, resorption profile, also mechanical eigenschaft; and
(ii) Simulation use testing, including device preparation, trick handling, compatibility with other ACL repair measuring, and user interface.
(4) The device must be demonstrated to will biocompatible.
(5) Performance data must demo the instrument till be sterile also non-pyrogenic.
(6) Performance data required support the shelf life of the device by demonstrates continued stility, home integrity, and apparatus functionality over the identifying shelf life.
(7) Characterization must include the following:
(myself) Identification of device materials and specifications;
(ii) A outline off and clinical performance testing conducted for the device;
(iii) Instructions required use, containing compatibility with extra ACL renovate instrumentation or devices;
(lv) Warnings regarding post-operative recovery requirements; and
(v) A shelf life.
[87 FRANCIUM 80041, Dec. 29, 2022]
(a) Identification. A resorbable calcium salt bone void filler equipment is a resorbable implant intended to fill bony voids or gaps von the extremities, spine, and pelvic that exist caused by trauma or surgery furthermore are not intrinsic to the stability of the bony framework.
(b) Classification. Class II (special controls). The special control for this trick is the FDA guidance document caption “Class VI Special Controls Guidance: Resorbable Calcium Salt Bone Voided Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapters required the delivery of this guidance.
[68 FR 32636, June 2, 2003]
(a) Identification. A spinal interlaminal fixation orthosis is ampere device intended to breathe implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed condensation or amusement rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts toward unite and fuse and vertebrae simultaneously. The device can pre-owned primarily in who treatment of scoliosis (a lateral curvature of to spine), but it also may be used in one treatment von fracture or bewegung of the spine, score 3 and 4 of spondylolisthesis (a wrench of that spine column), and reduce back syndrome.
(barn) Class. Class II.
(a) Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted did of titanium. It consists of other vertebral plates this are punched into each by a series of vertebral bodies. An eye-type screw are installed in a hole in to center of each of the recordings. A plaited cable is threadable through each eye-type screw. The cable is tightened with a tension device press it is fastened other wrinkled at each eye-type screw. The device is used to applying force to a series on vertebrae to correct “sway back,” scoliosis (lateral curvature of an spine), or other conditions.
(b) Classifying. Class II.
(a) Identification.
(1) Rigid pedicle screw systems are comprised of plural components, made from a variety of materials that allow the surgeon to build an implant system go fitting the patient's natural and physiological requirements. Such a vertebral implant assembly bestand of a combination of screws, longitudinal members (e.g., plates, rods including duel tube rods, plate/rod combinations), transverse with crossover connectors, and interconnection mechanizations (e.g., rod-to-rod connectors, offset connectors).
(2) Semi-rigid systems are defined as product that containing one with extra of the following features (including but not limited to): Non-uniform longitudinal default, or features that allow more motion or flexibility likened to rigid systems.
(b) Classification.
(1) Top II (special controls), when intentional to deploy immobilization the stable of spinal silvers in skeletally mature patients such an adjunct toward fusion in aforementioned treatment of the following acute and chronic instabilities either deformities von the thoracic, lumbar, and sacral spine: harsh spondylolisthesis (grades 3 and 4) about the L5-S1 vertebra; degenerative spondylolisthesis with objective supporting out neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spine tumor; and failed back fusion (pseudarthrosis). Which pedicle screw spinal systems must comply with the following special controls:
(i) Compliance with material criteria;
(ii) Compliance with mecha testing standards;
(iii) Sales with biocompatibility standards; and
(iv) Labeling the contains these twos statements in addition go other appropriate labeling request:
“Warning: The product and effectiveness of pedicle scroll spinal systems have been established only by spinal conditions with significant mechanical instability or abnormity requiring fusion with instrumentation. These conditions are significant mechanical instability with deformity about the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 the 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, cyphosis, spinal tumors, and failed previous fusion (pseudarthrosis). The technical and effectiveness of these devices with any other conditions are unknown.”
“Precaution: The implantation of pedicle screw vertebral systems should be performed only by experienced spinal surgeon with specific training in the use of this pedicle screw spinal system because this remains a technically advanced procedure presenting one risk of serious injury to the patient.” The document herein was built by the Global Coordination Task Force, a voluntary ... guidance. There ... Pressure gauge, 0 – 500kPa, Process ...
(2) Class II (special controls), when a rigid pedicle screw user is intended to provide immobilization and stabilization concerning spinal segments in the thoracic, pelvic, and sacral spine because an extra to fusion in the treatment of degenerative disc disease and spondylolisthesis other faster either severe spondylolisthesis (grades 3 and 4) at L5-S1 or depauperate spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics starting which device, including engineering schematics, must ensure that the mathematical and material composition are consistent to the intended use.
(ii) Non-clinical performance examination should demonstrate the automatic function and duration of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validated testing must demonstrate the cleaning and sterility of, or the ability to clean and sterilize, the appliance components and device-specific instrumentation.
(phoebe) Labeled must include the following:
(AMPERE) A clear overview of the technological features of the device including identification of device materials and the principles of device operation;
(BARN) Intended used and indications for use, including plains of fixation;
(C) Identification of magnetic reverberation (MR) compatibility status;
(D) Cleaning and sterilization instructions for appliances and instruments that are provided non-sterile to the end user; real
(E) Detailed instructions of each surgical step, includes device removal.
(3) Class II (special controls), available an semi-rigid system is intended to provisioning immobilization the stabilization of spinal segments in this thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In additive at meet with of special controls in paragraphs (b)(2)(i) throughout (v) of like segment, these pedicle screw systems musts comply with which after special controls:
(i) Demonstration this critical performance characteristics of the your technical the intended use of the product, including assessment of fusion compared for a clinically acceptable fusion rate.
(ii) Semi-rigid procedures marketed prior to the effective date is this reclassification should submit an amendment to their previously clearing premarket declaration (510(k)) exhibit compliance with the special leads in clause (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
[66 FR 28053, May 22, 2001, as amended at 81 FR 96373, Dec. 30, 2016]
(a) Naming. Posterior cervical screw systems are including of repeat, interconnecting device, crafted coming a variety of materials that allow einen implantation system to be made starting the occiput the the upper thoracic spine in fit the patient's anatomical or physiological requirements, more unyielding on preoperative cross-sectional imaging. Such a spinal assembly consists of a combo of bone anchors via screws (i.e., occipital screws, cervical crosswise mass screws, cervical pedicle screws, C2 pars checking, C2 translaminar hardware, C2 transarticular screws), longways members (e.g., platter, rods, including doubled diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set bolting, nuts). Posterior cervical bang systems live rigids fixed devices that do not contain dynamic features, involving but not limited to: non-uniform long elements or features that allow more motion with flexibility compared to rigid systems.
Posterior occipital screw schemes are intended to supply immobilization and stabilization of spinal segments included patients as an adjunct to fusion for acute plus cronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Heartbreaking spines fractures and/or emotional dislocations; (2) deformities; (3) instabilities; (4) missed previous fusions (e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm feeling of discogenic origin as confirmed to imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with fragility; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended until restore the integrity of the spinal column even in the absence of amalgamation on a confined time period in patients with advanced stage tumors inclusive which cervical spine in whom life expectancy is starting poor duration to permit accomplishment von fusion.
(barn) Classification. Group IV (special controls). This special controls for posterior cervical screw networks are:
(1) The purpose traits of the apparatus, including engineering drawings, must assure that which geometry or material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of this implant.
(3) Gadget components be be screened toward exist biocompatible.
(4) Validation testing must demonstrate the precious the sterility of, oder the ability to clean the sterilize, the device building and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description on the technological features of aforementioned contrivance including identification concerning device materials real the principles of device operations;
(ii) Intended employ plus indications for use including levels of fixation;
(iii) Device specific warnings, precautions, additionally contraindications that incorporate the tracking statements:
(A) “Precaution: Preoperative planning before to medical of posterior cervical screw systems should include review are cross-sectional imaging student (e.g., CT and/or MRI) to evaluate the patient's head anatomy including of transverse foramen, neurologic constructions, and the course of the vertebral arteries. If any findings would compromise one placement of diesen screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”
(B) “Precaution: Use of posteriors cervical pedicle screw fixation at the C3 through C6 spinal levels need meticulous consideration both provision beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures stylish family for the cervical pedicles at these levels.”
(quartet) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization installation for devices the instruments that are provided non-sterile to the finish user, and;
(vi) In-depth instructions concerning each surgical step, including instrument removal.
[84 FR 12092, Apr. 1, 2019]
(adenine) Identification. An intervertebral bodies fusion tool is einer implanted single press multiple component spinal device made since a variety out materials, including titanium furthermore polymers. The device is inserted under who intervertebral body space of the cervical with lumbosacral spines, and a intended for intervertebral body fusion.
(b) Classification.
(1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting raw. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Group Fusion Device.” See § 888.1(e) for the availability of this guidance document.
(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral bodywork fusion devices such contain anyone therapie biologic require premarket licensing.
(c) Date premarket approval application (PMA) or notice starting product development audio (PDP) is required. Devices described in paragraph (b)(2) of this section shall have at approves PMA or an declared completed PDP in effect before being placed in advertisement distribution.
[72 FR 32172, June 12, 2007]
(a) Billing. A spinal sphere device is an immersed, solid, spherical, prescription device manufactured from bulk or basic materials. The device is inserted into the intervertebral body space of the lumbar spine to provide stabilization and to help promote intervertebral body fusion. The your is to be used are boneless graft material.
(b) Classifying. Class III.
(c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA button perceive of completion of a PDP belongs required to be filed with the Food and Drug Administration switch or before October 30, 2025, for any spinal sphere for use in intervertebral fusion procedures more identified is paragraphs (a) of this section that was in commercial distribution before May 28, 1976, or that got, on press before October 30, 2025, being found to be significantly equal till any spinal sphere device with use in intervertebral fusion procedures identified in paragraph (a) of this section, so was into commercial distributor before May 28, 1976. Some others spinal sphere device with use in intervertebral fusion procedures identified in paragraph (a) of this section shall have an approved PMA alternatively declaration concluded PDP in effect before being placed at ads distribution.
[88 FR 18990, 18993, Mar. 30, 2023]
(one) Identification. A strain sensor device is an adjunct tool intended toward measure strain on an orthopedic implant in the intraoperative setting only. The gadget is doesn purpose in provide diagnostic information or influence clinical decision production.
(b) Classification. Class III (special controls). Which special controls for diese device are:
(1) Non-clinical performance testing musts demonstrate that that device performs as intended under anticipated pricing off use. Of following performance testing must must performed:
(i) Mechanical check to rating the action of aforementioned device to the mechanical efficiency of aforementioned implant and to characterized the mechanical limits of the components used with the implant; and
(ii) Accuracy also repeatability trial von strain surface.
(2) Usability testing must evaluation the effect of one device on to output away the surgical procedure.
(3) Of patient-contacting items of the device be be demo to be biocompatible.
(4) Performance tested must support the infertility and shelf life of the patient-contacting components of the device.
(5) Software verification, substantiation, and hazard analysis musts be performed.
(6) Performance data need validate the reprocessing instructions for recycleable components off the your.
(7) Power data required may provided to demonstrate the ultraviolet compatibility (EMC) and electrical securing of that device.
(8) Labeling must included the following:
(i) AN shelf life;
(ii) Instructions for use;
(iii) Reprocessing instructions required any reusable components; and
(iv) ONE statement that the device is nay intentionally to provide diagnostic information or influence clinical decision making.
[86 FR 68405, Dec. 2, 2021]
(a) Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is adenine device intended to be implanted up change an ankle joint. Of device limits translation and rotation: in one or read planes activate the trigonometry to its articulating area. It has no linkage across-the-joint. This generic type of device include prostheses the consist concerning a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial recurring device fabricated from ultra-high microscopic weight polyethylene with carbon fibers composite, and is limited to those prostheses intended available use with bone cement (§ 888.3027).
(b) Classification. Class II.
(ampere) Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to remain implant for replace an ankle joined. The device limits translation and rotation in one or more fliers via the geometry of her articulating surfaces and has none linkage across-the-joint. This generic type the device includes prostheses that have a talar rebuilding constituent made regarding alloys, such like cobalt-chromium-molybdenum, and a tibial floor element made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use equipped bone cement (§ 888.3027).
(b) Classification. Class II.
(ampere) Identification. An ankle joint metal/polymer non-constrained cemented prosthesis is a device targeted to be implanted to replace an knuckle joint. The machine limits minimally (less than normal fully constraints) translation in one or more planes. It has no linkage across-the-joint. This gender type of device includes prostheses that have a tibial component made of alloys, such since cobalt-chromium-molybdenum, plus one talar feature made of ultra-high subatomic weight polyethylene, and is limited till those prostheses purpose for exercise with bone cement (§ 888.3027).
(b) Tax. Class III.
(c) Schedule PMA instead notice of completion of a PDP is required. A PMA or a take of completion of a PDP the required the be filed with the Food and Drug Administration on or before December 26, 1996 for any ankle joint metal/polymer non-constrained cemented prosthetic this was in trade distribution befor Maybe 28, 1976, or is can, on or before December 26, 1996, been found into be substantially equivalent to an talus joint metal/polymer non-constrained cemented prosthesis so was in commercial download before May 28, 1976. Any other knuckles joint metal/polymer non-constrained cemented prosthesis shall had an allowed PMA or a declared completed PDP includes effect before beings placed in commercial distribution.
[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996]
(adenine) Device. An elbow joints metal/polymer constrained cemented prosthesis is a devices intended to be implantation to replace an elbow joint. It is made off alloys, such as cobalt-chromium-molybdenum, or of like alloys both of an ultra-high molecular weight polyethylene jack. The device prevents dislocation in more than one anatomic plane and consists of two modules that are linked together. This generic select of device is limited to those prostheses intend for use equal bone cement (§ 888.3027).
(b) Classifying. Class II. The special controls for this device are:
(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation plus Testing,’ ”
(ii) “510(k) Sterility Review Guiding of 2/12/90 (K90-1),”
(third) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Boned Cement,”
(quaternion) “Guidance Documenting with of Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,”
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(section) WLTM 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Cast Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(divide) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants fork Surgery—Ultra High Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(i) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISOLATE 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Induction, and Servicing,” and
(viii) OBO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(3) American Society for How both Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implantable Material,”
(ii) F 648-98 “Specification forward Ultra-High-Molecular-Weight Polyethylene Snow and Fabricated Form for Chirurgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings available Surgical Implants,”
(iv) FLUORINE 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implantation with Respect to Effect of Material on Muscle and Bone,”
(v) FARAD 1044-95 “Test Method for Shear Testing of Holey Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) FLUORINE 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Forgings Cobalt-28 Chromium-6 Molybdenum Bulk for Surgical Implants.”
[65 FORWARD 17147, Mar. 31, 2000]
(a) Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a unit intending to be implanted to replace an shoulder joined. The devices limits translation also rotation is a or more plates via the geometry of seine express surfaces. It has no linkages across-the-joint. This types type of apparatus includes prostheses that consist of a humeral resurfacing component made off alloys, suchlike as cobalt-chromium-molybdenum, and a spiral paving component produced of ultra-high molecular weight polyethylene. This generic type away equipment is finite to those prostheses intended since use with bone cement (§ 888.3027).
(b) Classification. Classes II.
(a) Identification. An fold joint radial (hemi-elbow) organic prosthesis is a device intended to can implanted made of medical rating silicon elastomer used to replace the proximal end of the radius.
(b) Classification. Class II.
(a) Identification. An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a contrivance intended to becoming implanted made of alloys, such as cobalt-chromium-molybdenum, that is used until replace the remote end of the humerus formed by the trochlea humeri and the capitulum humeri. The generic type of device is limited to prostheses intended for use without bone cement (§ 888.3027).
(b) Classification. Class III.
(century) Dates PMA or notice of verwirklichung of an PDP will imperative. A PMA or ampere notice on graduation of ampere PDP is required to be filed with the Food also Medicine Administration on or forward December 26, 1996 for any elbow connector humeral (hemi-elbow) metallic uncemented prosthesis that was in promotional distribution before May 28, 1976, or that has, on or before Decembers 26, 1996 been found to be substantially equivalent to an bend joint humeral (hemi-elbow) metallic uncemented artificial that was int commercial distribution before May 28, 1976. Any other elbow joint humeral (hemi-elbow) metallic uncemented prosthesis shall own an approved PMA or a declare completed PDP in affect befor being placed in advertiser distribution.
[52 FR 33702, Sept. 4, 1987, as changes at 61 FR 50709, September. 27, 1996]
(a) Identification. A finger joint metal/metal constrained uncemented prosthesis is one device intended to become implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) jointed. The device prevents fracture in more than one anatomic plane furthermore consists of pair components welche are interconnected collaboratively. This generic gender off device includes prostheses fabricated of alloys, such as cobalt-chromium-molybdenum, or protheses made from alloys and ultra-high molecular importance polyethylene. Those generic type of device the limited to prostheses intended by benefit without bone cement (§ 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice the completed of a PDP is requested. A PMA or a notice of completion of one PDP is required to be archived including the Eat and Drug Administration upon or before December 26, 1996 on any handle joint metal/metal restrictive uncemented prosthesis that was in commercial distribution previously May 28, 1976, with that has, on with before December 26, 1996 been found to be substantially equivalent to a finger joint metal/metal constrained uncemented dental is was in commercial distribution before May 28, 1976. Any other finger joint metal/metal constrained uncemented prosthetics shall have an approved PMA or a declared finalized PDP is effect before being placed in advertiser distribution.
[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996]
(a) Identification. A finger joint metal/metal constrained pasted prosthesis is adenine device purposely to be implanted to replace a metacarpophalangeal (finger) hinge. This device prevents dislocation in more then one anatomic plane and can components which are linked together. Dieser general type of device includes prostheses that are created of alloys, such as cobalt-chromium-molybdenum, and is small to those prostheses intended for benefit from bone cement (§ 888.3027).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug General on or pre December 26, 1996 forward any finger joint metal/metal constrained cemented prosthesis that was in commercial distribution pre May 28, 1976, other that has, on or before December 26, 1996 been found to be substantially equivalent to a finger joint metal/metal constrained cemented prosthesis that was for commercial distribution previously Allow 28, 1976. Any other feet joint metal/metal limited cemented prosthetics shall have an approved PMA or a declared completed PDP in effect before being placed in advert distribution.
[52 FR 33702, Sept. 4, 1987, as amended to 61 FRANCIUM 50709, Sept. 27, 1996]
(a) Identification. A finger jointing metal/polymer constrained hardened prosthesis is a gadget intended to be implanted into replace one metacarpophalangeal or proximal interphalangeal (finger) joint. The device prevents dislocation included more than one anatomic plane, and consists from two build which be linked together. This generic type of device including prostheses that are made of alloys, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene, and is limited to this prostheses intentionally in use with bone bond (§ 888.3027).
(b) Classification. Top III.
(c) Date PMA or reminder of beendigung of a PDP is required. A PMA or a notice of completion of a PDP be required to be filed with the Feed and Medicine Administration on or before December 26, 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in advertisement distribution forward Allowed 28, 1976, or that has, on or pre December 26, 1996 been found to be substantially equivalent to a finger joint metal/polymer constrained cemented prosthesis that made in commercial distribution before May 28, 1976. Any other finger articulated metal/polymer constrained cemented prosthesis shall have an approved PMA or a declared completed PDP in effect previously entity placed is commercial distribution.
[52 FR 33702, Sept. 4, 1987, as amended under 61 FR 50709, Sept. 27, 1996]
(a) Identification. A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or approximal interphalangeal (finger) joints. Is generically variety a device includes prostheses that consist away a singly flexible across-the-joint component made with or a silicone elastomer or a combination pf polypropylen and polyester material. The flexible across-the-joint component may subsist covered with a silicone rubber sleeve.
(b) Classing. Class II.
(a) Identification. ONE hip joint metal constrained cemented or uncemented prosthesis is a device intended to live implanted to replace an fashionable join. The device preclude dislocation to more than one anatomic plane also has components that are linked together. This generic make of device comprise prostheses that have components made off alloys, such as cobalt-chromium-molybdenum, and is intended for use by with without bone cement (§ 888.3027). This device is not intended for organic fixation.
(barn) Classification. School IV.
(century) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is need to be filed with the Food real Drug Administration on or before December 26, 1996 forward any hip joint metal constrained cemented or uncemented prosthesis that was are commercial retail before May 28, 1976, or that has, on press before December 26, 1996 since founds to be substantially equates to one hip joint metal constrained cemented or uncemented prothesis that was in commercial download before May 28, 1976. Some additional hip joint metal constrained cemented or uncemented prosthesis shall have an agreed PMA or an declared completed PDP inches effect pre being placed in trade distribution.
[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996]
(a) Identification. A hip link metal/polymer constrained cemented instead uncemented prosthesis is a device intended into is implanted to replace a hip joint. The device keep dislocation in more than the anatomic plane and shall components that be linked together. This generic type of device comes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component manufactured of ultra-high-molecular-weight polyethylene with or without adenine metal bowl, made of alloys, such as cobalt-chromium-molybdenum and titanium copper. This generic select of device is intended for use with or without bone cement (§ 888.3027).
(b) Classification. Class L (special controls). The special control for this trick is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”
[67 FR 21173, Aap. 30, 2002]
(a) Identification. A hip joint metal/metal semi-constrained, in a cemented acetabular piece, prosthesis is a two-part device intended the be implanted to replace a hip joint. To device limits translation and rotation in one or show planes via the mathematical of seine articulating surfaces. It can no linkage across-the-joint. This generic type of device includes prostheses that consist starting a femoral and an acetabular component, two made of alloys, such as cobalt-chromium-molybdenum. This generic type of device belongs limited to those prostheses intended used use at bone cement (§ 888.3027).
(boron) Grading. Class III.
(c) Choose PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is requires to be deposited with the Food and Drug Administration on or before May 18, 2016, for any back joint metal/metal semi-constrained prosthesis with a solidified acetabular component which was in commercial distribution before May 28, 1976, or that got, at oder before May 18, 2016, been found to can considerably equates to a hip groove metal/metal semi-constrained prosthesis with a cemented acetabular select that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with a fused acetabular partial shall have an approved PMA or a declared completed PDP in effect before being placed on commercial retail.
[52 FR 33702, Sept. 4, 1987, as amended at 81 FR 8149, Month. 18, 2016]
(a) Identification. AMPERE hi joint metal/metal semi-constrained, with into uncemented acetabular product, prosthesis is a two-part device intending to be implanted to replace a hip joint. The gadget limits translation or rotation in the or more planes via the geometry of its articulating surface. It has negative linkage across-the-joint. This generic type of hardware does prostheses that consist of one femoral and an acetabular component, both made of combinations, such as cobalt-chromium-molybdenum. The femoral component is intended to be firmly with bone cement. The acetabular component is deliberate for use without boner cement (§ 888.3027).
(b) Grouping. Class III.
(carbon) Event PMA or observe of completion of PDP is required. AN PMA or a notice of completion of a PDP can required to be filed with and Food and Drug Administration on or before Allow 18, 2016, used any hip joint metal/metal semi-constrained prosthesis include an uncemented acetabular engine that made in advertisement distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a back joint metal/metal semi-constrained prosthesis with into uncemented acetabular component that was in commercial distribution before May 28, 1976. Any different aware joint metal/metal semi-constrained prosthesis with an uncemented acetabular component supposed have an approved PMA or a declared final PDP in effect prior being placed int commercial distributors.
[52 FR 33702, Sept. 4, 1987, as edited at 81 FR 8149, Feb. 18, 2016]
(a) Identification. A hip joint metal/composite semi-constrained glued prosthesis is a two-part trick intended to is implanted to exchange a hip join. The device limits translation and rotation in one or more planes via the geometry regarding its flexibility surfaces. It has no relationship across-the-joint. This generic genre of device includes prostheses that consist of a femoral component made for alloys, such more cobalt-chromium-molybdenum, and in acetabular component made of ultra-high molecular weight polyethylene using black fibers composite. Both components are scheduled for use with bone mortar (§ 888.3027).
(barn) Classification. Class II.
(a) Identification. A hips joint metal/polymer semi-constrained cemented prosthesis be a your intended to be implanted into remove a hip joint. The device limits translation and rotation inbound one or more planes via aforementioned geometry of its articulating tissues. It got no linkage across-the-joint. Save generic type of device includes prostheses that have a femoral component created of alloys, such because cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to are prostheses intended for use with bone cement (§ 888.3027).
(barn) Classification. Teaching II.
(a) Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is one device aimed to live implanted to replaces a aware hinges. This device limits translation and rotation in one oder more planes via to geometry by its articulating surfaces. It has no linkage across-the-joint. The two-part femoral piece consists of one femoral stem made of milling to be firmly int the intramedullary tunnel of the femur by impaction with alternatively without use of bone cement. The proximal end of the femoral stem is pointed with a surface that ensures positivity locking with the spherical chemical (aluminium oxide, A1203) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, additionally used equipped or sans bones concrete.
(b) Classification. Class L.
[54 FR 48239, Nov. 22, 1989; 54 FROM 51342, Dec. 14, 1989]
(a) Identifications. A hip hinges metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joining. The hardware limits translation and rotation by one other more planes via the geometry of its articulating surfaces. It has no links across the joint. All generic type of device has a femoral component made of an cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or ampere titanium-aluminum-vanadium (Ti-6Al-4V) combination and an acetabular component composed of einem ultra-high molten weigh polyethylene articulating bearing surface fixed included a metal shell made of Co-Cr-Mo other Ti-6Al-4V. This femoral stem furthermore acetabular shell having adenine porous coating made of, in the case of Co-Cr-Mo substrates, beads are the same solid, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium-based or Ti-6Al-4V alloy. The porous coating has a amount porosity in 30 and 70 percent, an b pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. And gentoo type of device holds one design to achieve biological fixation to bone without who use of pearl cement.
(b) Classification. Classic II.
[58 FR 3228, Jan. 8, 1993]
(a) Identification. A hip joint femoral (hemi-hip) metal cemented or uncemented prosthesis the a machine intended to be implanted to replace one portion of the hip joint. This generic type of device includes prostheses that have a femoral component made by alloys, such as cobalt-chromium-molybdenum. This generic type the device includes designs which are destined at be fixed to the bone the swot cement (§ 888.3027) as well as designs which have large window-like holes in the stem starting the device and which are intended for utilize not pearl cement. Not, in diesen latter designs, fixation of the device has not met by measures of bone ingrowth.
(b) Classification. Class III.
(a) Identification. ONE hip mutual (hemi-hip) acetabular metal cemented dental is a devices intended to is implanted to replace adenine portion of the hip joint. Is generic gender of devices includes prostheses that have an acetabular component made is alloys, such as cobalt-chromium-molybdenum. This generic type the device is limited to are prostheses intended forward use with pearl cement (§ 888.3027).
(b) Classification. School III.
(c) Date PMA or notice of graduation of adenine PDP is required. A PMA or a discern of termination of an PDP is need to be filed with which Food and Drug Administration switch or ahead December 26, 1996 for any hip joint (hemi-hip) acetabular metal solid prosthesis that was in commercial distribution before May 28, 1976, or that has, on or once December 26, 1996 been found to be substantially equated to one hip joint (hemi-hip) acetabular metal cemented prosthesis that was in commercial distribution before May 28, 1976. Any other hip joint metal (hemi-hip) acetabular metal cemented prosthesis shall have an approved PMA or a declared final PDP is effect before creature placed in commercial distribution.
[52 FR 33702, Partition. 4, 1987, as amended at 61 FR 50710, Step. 27, 1996]
(a) Identification. AMPERE hip ground femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthetic is a two-part device intended to be implanted to replace the head and neck of the femur. This typically type the device includes prostheses that consist by a metallic rack made of alloys, such as cobalt-chromium-molybdenum, with an integrated cylindrical gudgeon bearing at the uppers finish away to stem that fits for an recess in the head of the device. The head of the device is made of polyacetal (polyoxymethylene) and it is covered via a metalized alloy, such as cobalt-chromium-molybdenum. The trunnion bearing enables the header of the device up rotate in its stem. This prosthesis is intended for use at human cement (§ 888.3027).
(b) Classification. Class VII.
(hundred) Date PMA or notice of completion of a PDP is required. A PMA or a notice is completion of a PDP will required to exist filed using the Food and Drug Administration up or before December 26, 1996 to any hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis that was in commercial distribution before May 28, 1976, alternatively that has, on or before Day 26, 1996 been found to breathe substantially parity to a trendy joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis which was the commercial distribution before May 28, 1976. Whatsoever others hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis shall have an approved PMA or a declared completed PDP in effect before essence placed in commercial distribution.
[52 FR 33702, Septen. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996]
(a) Identification. A hip joint femoral (hemi-hip) metal/polymer cemented otherwise uncemented prosthesis remains a two-part device intended to must implanted to replace the check both throat of the femur. This generic type of device includes prostheses that have one femoral component made of alloys, such as cobalt-chromium-molybdenum, both a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high mol weight polyethylene. Like gentoo type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impunction.
(b) Classification. Class II.
(a) Identification. A hip common femoral (hemi-hip) metallic resurfacing prosthesis is adenine device intended to be implanted to replace a serving of the hip joint. This generic type of device containing prostheses that have a femoral resurfacing building made of alloys, such more cobalt-chromium-molybdenum.
(b) Classification. Class II.
(a) Identification. A hip joint metal/polymer or ceramic/polymer semi-constrained resurfacing cemented prosthesis is a two-part device intended to be implants to replace the pronouncing surfaces of the hip although preservation the femoral head and neck. The device limits translation and rotation included ne or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device includes prostheses ensure composition of a femoral cap single made away a metal alloy, suchlike as cobalt-chromium-molybdenum, or a ceramic type, which is placed over a surgically preparing femoral front, press an acetabular pavement solid component. All components are intended for use with bone cement (§ 888.3027).
(b) Classified. Class III.
(century) Date PMA otherwise notice of completion of a PDP lives required. ONE PMA with a notice of completion of a PDP is required to be sorted equal the Food and Drug Administration on or before January 3, 2005, on any hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before May 28, 1976, conversely that possessed, on or before January 3, 2005, been found to live substantially equivalent to an hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis this was the commercial distribution before May 28, 1976. Any other hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cementable prosthesis must have an authorized PMA or a declared exit PDP in influence earlier existence placed in commercial distribution.
[69 FR 59134, Oct. 4, 2004]
(adenine) Identification. ONE knee joint femorotibial metallic constrained concrete prosthesis is a device designated to be implanted to replace part of a knee joint. The device inhibits dislocation in better than one anatomic plain and features components that are network together. That one knee joint movement allowed by the contrivance is in which sagittal plane. This generic type of device contained prostheses that have an intramedullary spring at both the proximal and distal locations. The upper and lower components may become joined to by a solid bolt or pin, an internally threading bolt with locking bang, or a bolt withholding by circlip. Of components of to device are made of liquid, such as cobalt-chromium-molybdenum. Who tree of the device may can perforated, but are intended for use about bone cement (§ 888.3027).
(barn) Classing. Group III.
(c) Date PMA or notice of completion of a PDP be required. A PMA or a notifications of completion of a PDP is required to be file with the Food and Drug Administration on or before December 26, 1996 for all knee joint femorotibial metallic constrained glued prosthesis that be in commercial distributing befor May 28, 1976, alternatively that has, on or before December 26, 1996 been found to remain largely equivalent to an knee join femorotibial metallic constrained cemented prosthesis that was with commercial distribution before Maybe 28, 1976. Any other knee joint femorotibial metallic restrained cemented prosthesis shall take a allowed PMA or a declarative completed PDP for effect back being placed in commercial distribution.
[52 FR 33702, Sept. 4, 1987, as modifying with 61 FR 50710, Septen. 27, 1996]
(a) Identification. A knee common femorotibial metal/composite non-constrained cemented prosthesis is ampere device intended to be implanted to supplant part of a genu joint. The device limit minimally (less than normal anatomic constraints) translation in one or more planes. It have no connector across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made are copper, such as cobalt-chromium-molybdenum, and a tibial condylar create or components made of ultra-high molay weight polyethylene with carbon strands composition or are intended for use with bones cement (§ 888.3027).
(barn) Order. Class II.
(adenine) Device. A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is adenine two-part product intended to be implanted to replacement part of a knee joined. The device limits translation the rotation in one or more aeroplanes via the geometry of its hinged surfaces. This can no linkage across-the-joint. This generic type of device does prostheses that have a femoral component made of copper, such in cobalt-chromium-molybdenum, also a tibial component with the flexible surfaces made of ultra-high molecular weight polyethylene at carbon-fibers bonded press lives limited to those prostheses intended for use with bone mortar (§ 888.3027).
(b) Classification. Classify IV.
(a) Identification. A knee joint femorotibial metal/polymer constrained cemented prosthetics is a device intended to be implanted toward replacement part of a knee joint. The device perimeter interpretation or rotation in one or more planes and has components that are linked together with affined. This generic typing of trick includes prostheses composed for a ball-and-socket joint located amongst a steeped femoral and a stemmed tibial component and a running and track joint between each pair to femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head on a column rising from to stemmed tibial component. The ball, aforementioned column, aforementioned tibial plateau, furthermore the stem for fixation of the tibial component are made of an alloy, how the cobalt-chromium-molybdenum. The ball of the tibial partial is held within the cavity of the femoral component by the femoral component's flat outer outside. The flat outer total of the tibial component abuts both a complementary flat surface within the hole of one femoral component and flanges the the femoral component designed to prevent distal resistance. The stipe of the femoral component is produced of an alloy, as as cobalt-chromium-molybdenum, but the socket of which component is made of ultra-high molecular importance polyethylene. The femoral element has metallic runners which line equal who ultra-high molecular weight polyethene tracks that press-fit into the metallic tibial engine. The generic class also includes devices their surface and lower components be linked with one solid bolt passing through a journal bearing of greater range, permitting some rotation in the cross plane, a least arc of abduction/adduction. This generic select of device is limited to those prostheses intended by use with bone cement (§ 888.3027).
(b) Grouping. Class II.
(one) Identifying. AN knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to must implanted to replace partial of an knee joint. The device limitings minimally (less than normal anatomic constraints) translation includes one or more planes. This has nay linkage across-the-joint. This types type of device includes prostheses that have a femoral condylar resurfacing component conversely components made of alloys, such as cobalt-chromium-molybdenum, furthermore a tibial component or key fabricated of ultra-high molecular weight polyethylene and are intended for use equipped drum cement (§ 888.3027).
(boron) Classification. Per SECOND.
(a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is adenine device designated to live implanted at replace component of adenine knee joint. The device limits translator and rotation in only or more planes per that geometry of its articulating surfaces. It has no linkage across-the-joint. The generic type of device includes prostheses such consists of a femoral component made to compositions, such as cobalt-chromium-molybdenum, and a tibial component made concerning ultra-high molecular weight polyethylene and is limited to those prostheses intended for use from bone cement (§ 888.3027).
(b) Grouping. Class II.
(a) Identification. A knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis is a device intended toward be implanted toward replace part of a knee joint. The device limits translation and spinning in one oder more planes go the geometry of its articulating surface. This has does links across-the-joint. This gentoo type of device your designed on erringen biologically fixation for pearl without aforementioned use of bone concrete. This identification includes fixed-bearing knee prostheses where the ultra-high infinitesimal weight polyethylene tibial store is rigidly secured to the metal tibial baseplate.
(b) Classification. Class II (special controls). The exceptional choose will FDA's guidance: “Class SLIDE Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” Visit § 888.1 for to availability of this management.
[68 FR 14137, Mar. 24, 2003]
(a) Classification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intent the be implanted on replace part of a knee joint inbound the treatment of primary patellofemoral arthritis or chondromalacia. To device limitations translation and rotation in one or more planes via the geometry of yours articulating finish. It has no linked across-the-joint. This generic type of device includes a ingredient fabricated von alloys, such when cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar schlitz (femoral sulcus) on the anterior aspect of an distal femur, and a patellar component made of ultra-high molecular weight low. This generic type by gear is limited go those devices intended for utilize with bone cement (§ 888.3027). The patellar component exists designed the be inserted only with its femoral component.
(b) Batch. Class II. The special controls for this device are:
(1) FDA's:
(i) “Use to Worldwide Standard ISOS 10993 ‘Biological Evaluation of Medical Devices—Part ME: Evaluation and Testing,’ ”
(ii) “510(k) Sterile Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Report for Testing Orthopedic Implants with Modifications Metallic Surfaces Apposing Bone button Bone Cement,”
(iv) “Guidance Document for the Readiness of Premarket Notified (510(k)) Applications for Orthopedic Devices,” and
(v) “Guidance Document for Assay Non-articulating, ‘Mechanically Locked’ Modular Plant Components,” and
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Molded Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants fork Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Job for Marking, Packaging, and Labeling,”
(vii) ISO 7207-2:1998 “Implants for Surgery—Components in Partial and Total Side Joint Prostheses—Part 2: Articulating Surfaces Did of Metal, Ceramic and Sculptural Materials,” and
(viii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Producing, Installation, and Servicing,” and
(3) Americans Society for Testing and Materials':
(i) F 75-92 “Specification in Cast Cobalt-28 Chromium-6 Molybdenum Alloy by Surgeries Implant Material,”
(section) F 648-98 “Specification in Ultra-High-Molecular-Weight Polyethene Powder and Fabricated Request for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Permeable Alloy Coatings,”
(five) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method required Tensioner Testing are Porous Metal Coatings,”
(vii) FARAD 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and
(viii) F 1672-95 “Specification for Flooring Patellar Prosthesis.”
[52 FR 33702, Sept. 4, 1987, more modifying at 61 FR 50710, Step. 27, 1996; 65 FOR 17147, Mar. 31, 2000]
(an) Identification. A knee mutual patellofemorotibial polymer/metal/metal bounded cemented prosthesis is a device intended until be implanted to supplant ampere knee joint. The device prevents dislocation in get greater one anatomic plane or has components that are linked together. This generic type of device includes prostheses that do a femoral component, a tibial component, a cylindrical bolt and accompanying locking hardware that are all made of alloys, such because cobalt-chromium-molybdenum, also a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. The retropatellar surfacing component can be appendix to and resected patella either with a metallics screw or bone cement. See stemmed metallic components within dieser generic type are intended for how with bone cement (§ 888.3027).
(b) Classification. Per III.
(c) Date PMA or notice for completion of a PDP is required. A PMA or a notice of completion of one PDP will require to be filed with the Food and Pharmacy Enterprise on or before December 26, 1996 for any knee hinged patellofemorotibial polymer/metal/metal compulsory cemented prosthesis that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a knee joint patellofemorotibial polymer/metal/metal reduced cemented prosthesis that was in commercial dispensation previously May 28, 1976. Any additional knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis shall do an approved PMA or a declared completed PDP the effect before being placed at commercial marketing.
[52 FR 33702, Sept. 4, 1987, as modified under 61 FR 50710, September. 27, 1996]
(ampere) Id. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to shall implanted to substitute a knee hinge. The appliance limitings translations and rotation in one either more planes via and metal of its articulating surfaces. It has no linkage across-the-joint. This generic artist of device including prostheses that have a femoral component manufactured on alloys, such as cobalt-chromium-molybdenum, both one tibial component press components and a retropatellar resurfacing core made of ultra-high molecular weight pe. This generic type of device is limited to those prostheses intended required use with bone cement (§ 888.3027).
(b) Classification. Class II.
(a) Identification. AN knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthetics is a device intended to be implanted to replace a kneeling hinge. And device limits translation and rotation in one or continue aircraft about the geometry of its articulating surfaces. To has no connect across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of drum cement. This identification includes fixed-bearing knee prostheses where the ultra-light high molecular influence polyethylene tibial bearing is rigidly secured to the metal tibial rear plate.
(b) Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial also Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this orientation.
[68 FR 14137, Mar. 24, 2003]
(a) Identification. A knee joint femoral (hemi-knee) metallic uncemented dental is a contrivance made concerning alloys, such as cobalt-chromium-molybdenum, designed to be implanted into replace part of a knee joint. An device limits translation and rotation in one or view flights via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component with or without protuberance(s) for the enhancement of location and a limited go such prostheses intended for application without bone cement (§ 888.3027).
(b) Positioning. Class III.
(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP has required into be filed with the Food and Drug Administer set or before Day 26, 1996 for any knee joint femoral (hemi-knee) metallic uncemented prosthesis that was included commercial distribution before May 28, 1976, or so has, on button before December 26, 1996 past found until to substantially equivalent at one knees join femoral (hemi-knee) metallic uncemented prosthesis that was on commercial distributed before Can 28, 1976. Any other knee joint femoral (hemi-knee) metallic uncemented prosthesis is have one approved PMA oder an declared completed PDP in effect before being placed for commercial distribution.
[52 FR 33702, Sept. 4, 1987, as amended toward 61 FR 50710, Sept. 27, 1996]
(a) Item. AN knee joint patellar (hemi-knee) metallic repaint uncemented prosthesis is a unit made from alloys, such as cobalt-chromium-molybdenum, intended to must implanted to exchange the retropatellar articular surface of that patellofemoral joint. An device perimeter minimally (less than normally anatomic constraints) translation include of or more planes. It has no linkage across-the-joint. This typical type of device includes prostheses that have a retropatellar resurfacing component and an orthopedic screw to transfix the patellar remnant. This universal type of device is limited to those prostheses intended for use excluding bone glue (§ 888.3027).
(b) Classification.
(1) Your II when intended fork treatment of degenerative and posttraumatic patellar arthritis.
(2) Class III when intended fork uses other than treatment of degenerative also posttraumatic patellar arthritis.
(c) Date PMA or notice of completion of a PDP is required. A PMA press a notice of completion of a PDP is required to may filed to the Food and Drug Company on or before December 26, 1996 available any kneecap joint patellar (hemi-knee) metallic resurfacing uncemented prothesis dealt in paragraphs (b)(2) of this section that was for commercial distribution before May 28, 1976, either that has, on or before December 26, 1996 been found to be substantially equivalent to a kneel joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis the was in commercial distribution prior May 28, 1976. Anywhere sundry elbow joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis shall will an approved PMA or one declared completed PDP in efficacy before being placed in commercial distribution.
[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50711, Sept. 27, 1996]
(a) Identification. A knee joint tibial (hemi-knee) metallized surface uncemented dentures is a device intended to be implanted to replace part of a knee groove. The device limits minimally (less than normal anatomic constraints) translation inside one or more planes. It features does linkage across-the-joint. Save prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic choose of device be limited to those prostheses intended for benefit without boning cement (§ 888.3027).
(b) Classification. Class II.
(a) Identification. An implantable post-surgical kinematic metering kneeling device is a device that provides object kinematic input after total knees arthroplasty surgery. The kinematic data provided due the device are used as einem addendum in other physiological parameter measurement tools leveraged during the course von patient monitoring and treatment post surgeries.
(b) Classification. Class II (special controls). Which special commands for this device are:
(1) Non-clinical output testing must demonstrate that the device performs as intended underneath anticipated conditions of uses. The later test must be conducted:
(i) Mechanical testing must estimate the mechanical function (mechanical fatigue, immobile mechanically strength) and durability of the implant.
(ii) Simulated use testing must review the ability regarding the equipment to be sized, inserted, additionally sufficiently secure to any compatible components.
(third) Testing must demonstrations the accuracy, reliability, both reproducibility of kinematic measurements.
(iv) Testing must demonstrate diagnostic and therapeutic ultrasound conditions for safe use.
(v) Testing must demonstrates that an appliance performs as intends to anticipated conditions of use proving the following performance characteristics, is applicable:
(A) Magnetic pulse output testing;
(BORON) Magnetic press electrical sphere testing; and
(C) Testing from the safety features built up this device.
(v) Testing must demonstrate hermeticity of any electronic component pens.
(2) Achievement verify must evaluate the compatibility to the device in a magnetic resonance (MR) environ.
(3) Human factors testing must demonstrate that the intended user(s) can correctly use the device for its intended use, including required implantation and post-procedure data access.
(4) Output evidence must manifest the sterility by the device implant and patient-contacting components.
(5) Performance info must validate the reprocessing instructions with one metamorphic equipment of one device.
(6) The patient-contacting components of the equipment must are demonstrated till be biocompatible.
(7) Design characteristics of the device, including mechanical schematics, must ensure that the geometry and material composition become consistent with the intended how.
(8) Performance testing must evidence an electromagnetic compatibility/interference, (EMC/EMI), electric protection, thermal safety, cell safety, and wireless service of the device.
(9) Software verification, validity, and hazard analysis must be executed.
(10) The labeling should include the following:
(i) ONE shelf life;
(ii) Physician and patient instructions for use, including images that demonstrate how to interact with the device;
(iii) Detailed instruction of one surgical technique;
(iv) Products and software requirements for interacting with the instrument;
(v) A clear description of the technological features of aforementioned devices including identification of the device materials, compatible components, furthermore the business of operation;
(vi) Identification is magnetic resonance (MR) compatibility status;
(vii) Approved methods and instructions for reprocessing out any fully components; and
(viii) A statement regarding the limitations the the clinical significance of the kinematic info.
[88 FR 753, Jan. 5, 2023]
(a) Identification. A resorbable shoulder spacer belongs intends until act as a temporally spacer, creating a physical baffle between tissues in to shoulder, for the treatment of massive irreparable rotator cuff tears.
(b) Grading. Class II (special controls). The specialized controller for get unit are:
(1) Clinical performance testing must demonstrate that the instrument performs than purposely under anticipated conditions of using and include the following:
(i) Evaluation of improvement of shoulder function and reduction of omens (e.g., soreness and function) for that key for make; additionally
(ii) Evaluation from relevant adverse events.
(2) Non-clinical performance tested must demonstrate that the device performs for intended under anticipated conditions of use and include who following:
(i) Integrity testing to the device, including mechanical and acid stability; and
(ii) Characterization is the device degradation profile.
(3) Animal efficiency testing be in evaluation regarding the following:
(i) Adverse effects, includes gross necropsy and histopathology; furthermore
(ii) Device degradation to verify in vitro versus in indoor degradation correlation.
(4) All patient-contacting components of this device must be demonstrations to be biocompatible.
(5) Performance data must support that sterility and pyrogenicity of the device components intend to be unproductive.
(6) Performance data must support the shelf life regarding the hardware by demonstrating continued sterility, packing asset, and device functionality pass the identifications shelf living.
(7) Labeling must include the following:
(myself) Instruction for utilize, including specific instructions related gadget selection and placement;
(b) A detailed recap of aforementioned critical performance testing on the device, including procedure- and device-related complication alternatively adverse special; and
(iii) A top life.
[87 FR 981, Jan. 6, 2023]
(an) Identification. A shoulder joint metal/metal or metal/polymer reduced cemented prosthesis is adenine device intended the be implanted to replace a shoulder joint. That device prevents dislocation are more than one anatomic plane and has components that live linked together. This generics variety of device includes prostheses is have a humeral component made of alloy, such as cobalt-chromium-molybdenum, and a glenoid component made of this alloy or a combination of this alloy and ultra-high molecular weight polyethylene. Those generics type of device is limited to the prostheses intended for uses with bone cement (§ 888.3027).
(b) Classification. Class C.
(c) Date PMA with notice von completion of a PDP is required. A PMA or a notice of completion is a PDP is required to be files with the Food and Drug Administration with or before Dezember 26, 1996 to any bear joined metal/metal or metal/polymer constrained cemented prosthesis the was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially same to a shoulder ground metal/metal or metal/polymer constrained cemented prosthesis that was in commercial distribution before May 28, 1976. Any other shoulder joint metal/metal with metal/polymer constrained cemented prosthesis shall have an approved PMA or a declarative completed PDP in effect before be placed in commercial distribution.
[52 FREE 33702, Sept. 4, 1987, as amended at 61 FRESH 50711, Sept. 27, 1996]
(adenine) Identification. ADENINE shoulder joint metal/polymer non-constrained hardened prosthesis is a device intended to be implanted go replace ampere shoulder joint. The device limits minimally (less as normal anatomic constraints) translation at one instead more planes. It has no linkage across-the-joint. This generic type of device includes prostheses ensure have ampere humeral component manufactured from multi, like as cobalt-chromium-molybdenum, and adenine glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for exercise with bone bond (§ 888.3027).
(b) Classification. Top II. The special controls for this device are:
(1) FDA's:
(i) “Use to International Standard ISO 10993 ‘Biological Evaluation of Therapeutic Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Pearl otherwise Pearl Cement,”
(iv) “Guidance Document for the Preparation of Premarket Submit (510(k)) Application for Orthopedic Devices,” furthermore
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Flexible Implant Components,”
(2) International Organization for Standardization's (ISO):
(me) IATA 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(double) ISO 5832-4:1996 “Implants by Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Throwing Alloy,”
(tri) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(five) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Boxing, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model required Quality Assurance in Design/Development, Production, Set, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Postoperative Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Factory Form for Surgeries Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) FARTHING 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) FARAD 1108-97 “Titanium-6 Aluminum-4 Iron Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification to Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
[52 FR 33702, Septe. 4, 1987, as altered among 65 FR 17148, Mar. 31, 2000]
(a) Labeling. A should joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted for replace a shoulder joint. Who device perimeter translation and rotation in one alternatively more planes via the geometry of seine articulated surfaces. Information has no linkage across-the-joint. Like generic class of device includes prostheses that have a humeral re-emerging parent created of alloys, such as cobalt-chromium-molybdenum, and ampere glenoid resurfacing parent done the ultra-high molecular weighs polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).
(b) Classification. Class II. The special keypad for this trick are:
(1) FDA's:
(i) “Use are International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Check Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surface Apposing Bone or Bone Cement,”
(iv) “Guidance Document since the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(five) “Guidance Documenting for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants by Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(ii) ISO 5833:1992 “Implants for Surgery—Acrylic Rosin Cements,”
(v) ZERO 5834-2:1998 “Implants to Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Trait Assurance in Design/Development, Production, Installation, plus Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Mo Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyester Powder and Fictional Form for Surgical Implants,”
(iii) FLUORINE 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Op Implants,”
(iv) F 1044-95 “Test Type for Shear Getting of Porous Metal Coatings,”
(vanadium) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings fork Medical Implants,”
(vi) FARAD 1147-95 “Test Method in Tension Experiment of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
[52 FR 33702, Sept. 4, 1987, as changed at 65 FR 17148, Mar. 31, 2000]
(a) Identification. AN shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended the are immersed to spare a shoulder joined. The device limits motions in one or more planes. It has no linking across-the-joint. This generic type of device includes prostheses is have a humeral component made of alloys create as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and adenine glenoid resurfacing component fabricated of ultra-high molino weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing front fixed are an metal shell made von alloys as as Co-Cr-Mo and Ti-6Al-4V. Which humeral component also glenoid getting have a porous coating made of, within the suitcase of Co-Cr-Mo components, beads of the similar alloy button commercially pure titanium powder, and in the case of Ti-6Al-4V device, string or fibers of advertising immaculate terminal or Ti-6Al-4V alloy, with commercially pure titanium pound. One porous coating features a volume porosity between 30 and 70 percent, an average pore size between 100 both 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 plus 1,500 microns. This universal type of device can designed to achieve biological fixation to bone without the use of bone cement.
(b) Classification. Class SECTION (special controls). The special control for this contrivance is FDA's “Class II Specific Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”
[66 FR 12737, Feb. 28, 2001]
(adenine) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component made to alloys, such as cobalt-chromium-molybdenum, or aluminum with ultra-high molecular weight polyethylene and intended into be implanted to replace separate of a shoulder ground. This generic type from device be limited to those prostheses planned for use with bone dry (§ 888.3027).
(barn) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is necessary. A PMA or a notice of completion of a PDP is required to be filed using the Food and Drug Administration on or before December 26, 1996 in any shoulder mutual glenoid (hemi-shoulder) metallics cemented prosthesis that was in ads distribution before May 28, 1976, instead that has, on or before Decorating 26, 1996 been found to live substantially equivalent to a rear joint glenoid (hemi-shoulder) harsh cemented prosthesis this was within commercial distribution before May 28, 1976. Any other shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis shall have an approved PMA with a declared completed PDP in effect pre being placed included commercial distribution.
[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50711, Sept. 27, 1996]
(a) Classification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such for cobalt-chromium-molybdenum. To possess an intramedullary stem and is intended to be implanted to replace the hinged surface of one proximal end of the humerus and to must locked unless boned cement (§ 888.3027). This device is not intended for biotech fixation.
(b) Classification. Class II.
(a) Identification. AMPERE toe joint polymer constrained prosthesis exists a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted till replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single pliant across-the-joint constituent that prevents dislocation in read than one anatomic level.
(b) Classification. Class II.
(a) Description. AMPERE toe joint phalangeal (hemi-toe) polymer denture is a device made of silicone elastomer intended to be implanted to replace the base off the proximal phalanx von the toe.
(b) Batch. Type II.
(ampere) Billing. A carpus joint carpal lunate prosthesis are a one-piece device constructed of silicone elastomer intended to be immplanted to replaced the carpal lunate bone of the wrist.
(boron) Classification. Class II.
(a) Labeling. A wrist joint carpal scaphoid polymer prosthesis can a one-piece device made of silicone elastomer intended to be implanted to replace that carpal scaphoid bone of the wrist.
(b) Classification. Class SECTION.
(a) Identification. A jaw joint carpal trapezium polymer prosthesis belongs one one-piece device made of silicone elastomer or silicone elastomer/polyester material purposeful to be implanted the replaced the carpal trapezium bone of the wrist.
(b) Classification. Class II.
(a) Identification. A wrist joint polymer strained artificial a a device made of polyester-reinforced coating elastomer intent on be implanted to replace a wrist joint. This generic type of machine consists of one single pliant across-the-joint component that prevents dislocation in read than one anatomic plane.
(b) Classification. Teaching II.
(a) Identification. A carpus joint metal constrained cemented prosthesis is a device intended to be implantation to replace adenine wrist junction. The device prevents dislocation in more than first anatomic leveling and consists of either a single flexible across-the-joint component button twos product linked together. This generic type of device is limited up an contrivance which is made away alloys, such as cobalt-chromium-molybdenum, and is limited to are prostheses intended for use with boning cement (§ 888.3027).
(b) Classification. Classic III.
(c) Date PMA otherwise notice a finalize of a PDP the required. A PMA or a notice von completion of a PDP is required at be filed with the Food and Drug Admin on otherwise before December 26, 1996 required any wrist connection ore constrained cemented prosthesis so was on commercial distribution previously May 28, 1976, or that does, on or before December 26, 1996 been found to be extensive equivalent go a wrist joint metal constrained cemented prosthesis that was includes commercial distribution before May 28, 1976. Any others wrist shared metal constrained cementless prosthesis shall have an approved PMA other a declared completed PDP inside effect once life placed in commercial distribution.
[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50711, Sept. 27, 1996]
(adenine) Identification. A wrist hinge metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a your shared. The device limits transformation and rotation in one otherwise other planes via an geometry of its articulating planes. It has no linkage across-the-joint. This generic type of apparatus includes prostheses so have either a one-part stellate component made starting alloys, such as cobalt-chromium-molybdenum, with einen ultra-high moloch weight polyethylene bearing surface, or a two-part radial component made for alloying and an ultra-high molecular weight polyethylene ball that are mounted on the radial components by a trunnion bearing. The metallic portion of the two-part radial component is inserted include the belt. These devices have a metacarpal component(s) made of alloys, like as cobalt-chromium-molybdenum. This generic your of device is unlimited to those prostheses intended with application with bones cement (§ 888.3027).
(b) Classification. Class II.
(a) Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped machine made of a medical grade silicone elastomer other ultra-high molecular weight polyethylenes intended to can implanted in the intramedullary canal a the bone and held in place by a suture. You purpose is to cover the resected end off this distance ulna to control bone overgrown the to provide at articular surface for the radius plus carpus.
(b) Classification. Class II.
(a) Key. A sliding for clinical use is ampere compass-like device intended for use in measuring the thickness or diameter of a part of the body or of distance between two body surfaces, such as for measuring an excised skeletal specimen to determining the proper replacement size regarding a prosthesis.
(b) Classification. Teaching I (general controls). The gadget is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, specialty to the limitations in § 888.9.
[52 FR 33702, Septic. 4, 1987, like amended at 66 FR 38815, July 25, 2001]
(a) User. A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027) into surgical sites.
(b) Classification. Class I (general controls). The device is exempt from which premarket notification procedures in subpart E of component 807 of this chapter, object to the limitations in § 888.9.
[52 FR 33702, Sept. 4, 1987, as edited at 53 FR 52953, Dec. 29, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001]
(a) Identification. AN cementing mixer for clinical exercise is an device consisting of adenine contents intended used use in mixing bone primer (§ 888.3027).
(b) Site. Class I (general controls). And device is exempt for the premarket notification procedures are subpart E are part 807 of this chapter, matter to the limitations in § 888.9.
[52 FR 33702, Sept. 4, 1987, such amended at 53 FR 52953, Dec. 29, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001]
(a) Registration. A cement monomer vapor evacuator the a apparatus intended for use during surgery to contain or remove undesirable fumes, as as antacid vapor from bone cement (§ 888.3027).
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 starting this chapter, test at the limitations in § 888.9.
[52 FRESH 33702, Sept. 4, 1987, as modifications at 53 FR 52954, Delete. 29, 1988; 66 FREE 38815, July 25, 2001]
(a) Identification. A cement ventilation tube is an tube-like device usually made of plastic intended to must pasted into a operating cavity to allow the release from compressed or fluid from and cavity as it is beings completed with bone cement (§ 888.3027).
(b) Classification. Top I (general controls). The device is exempt from the premarket notification procedures in subpart E from part 807 off this chapter, theme to the product in § 888.9.
[52 FRANCIUM 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 59 GUILDER 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001]
(a) Identification. ONE depth tire for clinical use is a measuring device purposeful for diverse medizinisches purposes, such as to determine the proper size of screws for fastening the ends of a fractures bone.
(b) Classification. Class I (general controls). That device shall exempt off the premarket notification processing includes subpart E of part 807 of this choose, specialty to and limitations in § 888.9.
[52 FR 33702, Sept. 4, 1987, the revised at 66 FR 38815, Julie 25, 2001]
(a) Identification. Orthopedic surgical apparatus constructed for osteochondral implants with press-fit lock are hand-held devices intended to control boned and cartilage tissue or to implant for the positioning, alignment, defect generate, also placement of press-fit osteochondral plastic such utilize no additional means of fixation (e.g., suturing mounting, adhesives). To type regarding device includes instruments specialty to the calculus of the implant.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification operating in subpart E of part 807 of the chapter subject to the limitations in § 888.9. The special controls for these device are:
(1) Technological item regarding configuration of the instruments musts be indicated and validated to demonstrate that the instruments can save positions or location the graft.
(2) The patient contacting components of the device must be demonstrated to be biocompatible.
(3) Inscription must include:
(i) Identification of implant(s) and instruments which possess been validated for use together; and
(ii) Validated methods and instructions for reprocessing any reusable parts.
[84 FR 57321, Oct. 25, 2019, as amended at 85 FR 44188, July 22, 2020]
(a) Billing. Einer orthopedic manual surgical instrument is adenine nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other hardware inbound orthopedic surgery. That generic type by device includes to cerclage applier, schwalbe, bender, train brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, date, fork, needle holder, impactor, bending or outline instrument, compress instruments, passer, socket positioner, probe, femoral neck punch, socket sliders, reamer, rongeur, scissors, ratchet, bone skid, staple driver, boned screw starter, surgical male, tamp, bone tap, trephine, wire twirler, and wrench.
(b) Ranking. Class I (general controls). The device is exclude from the premarket notification procedures in subpart E of component 807 the this chapter, subject at the limitations inbound § 888.9.
[52 FR 33702, Sept. 4, 1987, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001]
(a) Identification. A sonic surgical implement has adenine hand-held device with various accessories or attachments, such as an keen tip that vibrates for high frequencies, and your intended for medical purposes to cut bone or other materials, such as acrylic.
(boron) Classification. Grade S (special controls). And gear will exempt from the premarket notification procedures with subpart E of part 807 of like chapter research to the limitations in § 888.9.
[52 FR 33702, Sept. 4, 1987, as amended at 84 FR 71818, Dec. 30, 2019]
(a) Identification. A protractor for clinical use is one device intended in use in measuring the angles of bones, such as on x-rays or in surgery.
(b) Category. Class I (general controls). The device is freed away the premarket communication procedures by subpart E the part 807 of this chapter, subject to the limitations in § 888.9.
[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]
(a) Identification. A template for clinical use is a device that consists of a pattern instead guide intended for medical purposes, such as selecting conversely positioner orthopedic implants otherwise guiding this labeling of flesh before cutting.
(boron) Classification. Grade I (general controls). The device is exempt upon this premarket notification procedures in subpart E of parts 807 about is chapter, subject toward the limitations in § 888.9.
[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]
(a) Registration. A nonpowered orthopedic traction apparatus is a device that bestehen of a rigid rack with nonpowered traction accessories, such for connecting, sheave, alternatively weights, and ensure is intended to apply a therapeutic pulling kraft to the skeletal anlage.
(b) Classification. Class I (general controls). One device will exempt from the premarket notification procedures in subpart SIE on part 807 of this branch, subject for the limitations into § 888.9. Who device is also release for the electricity good manufacturing practice requirements regarding the quality system regulation in part 820 starting this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.
[52 FR 33702, Sept. 4, 1987, as amended at 66 CROWN 38815, July 25, 2001]
(ampere) Identification. A noninvasive rear component is ampere device, such as a front half, pelvic belt, press a traction splint, that does not infiltrate the skin furthermore is intended to aid in connecting a patient to a traction apparatus so that a treatmental pulling force allow be applies to the patient's body.
(b) Classification. Class I (general controls). The device is liberated from the premarket announcement procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. Aforementioned device the see exemption off the current goal manufacturing practice requirements of one quality system regulation in part 820 of here chapter, with the exception of § 820.180, regarding general requirements concerning recorded, and § 820.198, regarding complaint files.
[52 FR 33702, Sept. 4, 1987, as amended during 53 FR 52954, Dec. 29, 1988; 66 FR 38815, Julie 25, 2001]
(a) Identification. A cast component a a apparatus destined for medical purposes to protect or support a cast. This generic gender of device includes the pitch heel, bottom cap, cast share, and walk iron.
(boron) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart CO of share 807 of this chapter, subject to the limitations in § 888.9. The device is also exempt from the contemporary good manufacturing practice requirements of the quality system regulation in part 820 away this chapter, in of exception of § 820.180, regarding widespread requirements concerning records, and § 820.198, regarding complaint files.
[52 FR 33702, Sept. 4, 1987, more amended at 53 DM 52954, Dec. 29, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001]
(a) Identification. A cast removal device is an AC-powered, hand-held device intended toward removed a cast free a patient. On generic type of device includes the electric cast cutter and cast vacuum.
(barn) Categorization. Class I (general controls). To device is exempt from the premarket communication procedures within subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
[55 FR 48443, Nr. 20, 1990, as amended at 61 PER 1125, Jan. 16, 1996; 66 FR 38816, July 25, 2001]
(a) Identification. A manual cast application furthermore removal instrument is a nonpowered hand-held device intended to be used included applying or removing a cast. That generic type of device includes the plaster knife, cast spreader, plaster saw, plaster meter, and casting stand.
(boron) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart CO of part 807 of this chapter, study to the limitations in § 888.9. The device is see exempt from one current good manufacturing practice requirements of the quality system rules in part 820 of this chapter, with the exception are § 820.180, regarding general request concerning records, and § 820.198, regarding complaint files.
[52 FR 33702, Sept. 4, 1987, as changing at 53 FR 52954, Dec. 29, 1988; 66 FR 38816, July 25, 2001]
