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$888.5 Resurfacing technique.

Because of resurfacing techniques, certain joint prostheses require far less bone resection than other devices intended to repair or replace the same joint. The amount of bone resection may or may not affect the safety and effectiveness of the implantation of the prosthesis. When a resurfacing technique is used, the name of the prosthesis includes this information.

$888.6 Degree of constraint.

Certain joint prostheses provide more constraint of joint movement than others. FDA believes that the degree of constraint is an important factor affecting the safety and effectiveness of orthopedic prostheses. FDA is defining the following standard terms for categorizing the degree of constraint.

(a) A “constrained” joint prosthesis is used for joint replacement and prevents dislocation of the prosthesis in more than one anatomic plane and consists of either a single, flexible, acrossthe-joint component or more than one component linked together or affined.

(b) A "semi-constrained” joint prosthesis is used for partial or total joint replacement and limits translation and rotation of the prosthesis in one or more planes via the geometry of its articulating surfaces. It has no acrossthe-joint linkage.

(c) A "non-constrained" joint prosthesis is used for partial or total joint replacement and restricts minimally prosthesis movement in one or more planes. Its components have no acrossthe-joint linkage.

device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

(a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception

of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as quired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism directly from clinical material;

(7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the

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$888.9 Limitations of exemptions from

section 510(k) of the Federal Food,

Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II

assay is intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in $812.3(k) of this chapter; and

(9) For near patient testing (point of care). [65 FR 2321, Jan. 14, 2000)

Subpart B-Diagnostic Devices 8 888.1100 Arthroscope.

(a) Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

(b) Classification. (1) Class II (performance standards).

(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers,

knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (52 FR 33702, Sept. 4, 1987, as amended at 61 FR 1124, Jan. 16, 1996)

$888.1500 Goniometer.

(a) Identification. A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint.

(b) Classification. (1) Class I (general controls) for a goniometer that does not use electrode lead wires and patient cables. This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to $888.9.

(2) Class II (special controls) for a goniometer that uses electrode lead wires and patient cables. The special controls consist of:

(i) The performance standard under part 898 of this chapter, and

(ii) The guidance entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables." This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to $888.9. [65 FR 19319, Apr. 11, 2000)

8 888.1240 AC-powered dynamometer.

(a) Identification. An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.

(b) Classification. Class II.

8 888.1520 Nonpowered goniometer.

(a) Identification. A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807.

Subpart C [Reserved]

Subpart D-Prosthetic Devices

$888.1250 Nonpowered dynamometer.

(a) Identification. A nonpowered dynamometer is a mechanical device intended for medical purposes to measure the pinch and grip muscle strength of a patient's hand.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807.

8 888.3000 Bone cap.

(a) Identification. A bone cap is a mushroom-shaped device intended to be implanted made of either silicone elastomer ultra-high molecular weight polyethylene. It is used to cover the severed end of a long bone, such as the humerus or tibia, to control bone overgrowth in juvenile amputees.

or

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (52 FR 33702, Sept. 4, 1987, as amended at 61 FR 1124, Jan. 16, 1996]

function as a scaffold for soft tissue ingrowth.

(b) Classification. Class II.

$888.3010 Bone fixation cerclage.

(a) Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

(b) Classification. Class II. $888.3015 Bone heterograft.

(a) Identification. Bone heterograft is a device intended to be implanted that is made from mature (adult) bovine bones and used to replace human bone following surgery in the cervical region of the spinal column.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See $888.3. $ 888.3020 Intramedullary fixation rod.

(a) Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

(b) Classification. Class II. $888.3025 Passive tendon prosthesis.

(a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a polyester reinforced medical grade silicone elastomer intended for use in the surgical reconstruction of a flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for the ligament or tendon nor to

8 888.3027 Polymethylmethacrylate

(PMMA) bone cement. (a)

Identification. Polymethylmethacrylate (PMMA) bone cement (luting agent) is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid or copolymers containing polymethylmethyacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to the living bone.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See 8 888.3. 8888.3030 Single/multiple component

metallic bone fixation appliances

and accessories. (a) Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

(b) Classification. Class II.

$888.3040 Smooth or threaded metallic of vertebrae to correct "sway back," bone fixation fastener.

scoliosis (lateral curvature of the (a) Identification. A smooth or thread- spine), or other conditions. ed metallic bone fixation fastener is a

(b) Classification. Class II. device intended to be implanted that

8888.3070 Pedicle screw spinal system. consists of a stiff wire segment or rod made of alloys, such as cobalt-chro- (a) Pedicle screw spinal systems (1) mium-molybdenum and stainless steel,

Identification. Pedicle screw spinal sysand that may be smooth on the out- tems are multiple component devices, side, fully or partially threaded, made from a variety of materials, instraight or U-shaped; and may be ei- cluding alloys such as 316L stainless ther blunt pointed, sharp pointed, or steel, 316LVM stainless steel, 22Crhave a formed, slotted head on the end. 13Ni-5Mn stainless steel, Ti-6Al4V, It may be used for fixation of bone and unalloyed titanium, that allows fractures, for bone reconstructions, as the surgeon to build an implant system a guide pin for insertion of other im- to fit the patient's anatomical and plants, or it may be implanted through physiological requirements. Such a spithe skin so that a pulling force (trac- nal implant assembly consists of a tion) may be applied to the skeletal combination of anchors (e.g., bolts, system.

hooks, and/or screws); interconnection (b) Classification. Class II.

mechanisms incorporating nuts,

screws, sleeves, or bolts; longitudinal 8888.3050 Spinal interlaminal fixation

members (e.g., plates, rods, and/or orthosis.

plate/rod combinations); and/or trans(a) Identification. A spinal interlam- verse connectors. The devices are ininal fixation orthosis is a device in- tended to provide immobilization and tended to be implanted made of an stabilization of spinal segments in alloy, such as stainless steel, that con- skeletally mature patients as an adsists of various hooks and a posteriorly junct to fusion in the treatment of the placed compression or distraction rod. following acute and chronic instabilThe device is implanted, usually across ities or deformities of the thoracic, three adjacent vertebrae, to straighten lumbar, and sacral spine: degenerative and immobilize the spine to allow bone spondylolisthesis with objective evigrafts to unite and fuse the vertebrae dence of neurologic impairment, fractogether. The device is used primarily ture, dislocation, scoliosis, kyphosis, in the treatment of scoliosis (a lateral spinal tumor, and failed previous fucurvature of the spine), but it also may sion (pseudarthrosis). be used in the treatment of fracture or (2) Classification. Class II (special condislocation of the spine, grades 3 and 4 trols). Pedicle screw spinal systems of spondylolisthesis (a dislocation of must comply with the following special the spinal column), and lower back controls: syndrome.

(i) Compliance with material stand(b) Classification. Class II.

ards,

(ii) Compliance with mechanical test8888.3060 Spinal intervertebral body ing standards, fixation orthosis.

(iii) Compliance with biocompat(a) Identification. A spinal ibility standards, and intervertebral body fixation orthosis is (iv) Labeling which contains these a device intended to be implanted made two statements in addition to other apof titanium. It consists of various propriate labeling information: vertebral plates that are punched into “WARNING: The safety and effectiveeach of a series of vertebral bodies. An ness of pedicle screw spinal systems eye-type screw is inserted in a hole in have been established only for spinal the center of each of the plates. A conditions with significant mechanical braided cable is threaded through each instability or deformity requiring fueye-type screw. The cable is tightened sion with instrumentation. These conwith a tension device and it is fastened ditions are significant mechanical inor crimped at each eye-type screw. The stability or deformity of the thoracic, device is used to apply force to a series lumbar, and sacral spine secondary to

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degenerative spondylolisthesis with ob- ricated from ultra-high molecular jective evidence of neurologic impair- weight polyethylene with carbon fibers ment, fracture, dislocation, scoliosis, composite, and is limited to those proskyphosis, spinal tumor, and failed pre- theses intended for use with bone cevious fusion (pseudarthrosis). The safe- ment (888.3027). ty and effectiveness of these devices for (b) Classification. Class II. any other conditions are unknown.”

"PRECAUTION: The implantation of 8888.3110 Ankle joint metal/polymer pedicle screw spinal systems should be semi-constrained cemented

prosperformed only by experienced spinal

thesis. surgeons with specific training in the

(a) Identification. An ankle joint use of this pedicle screw spinal system metal/polymer semi-constrained because this is a technically demand- mented prosthesis is a device intended ing procedure presenting a risk of seri- to be implanted to replace an ankle ous injury to the patient.”

joint. The device limits translation and (b) Pedicle screw spinal systems for all rotation in one or more planes via the other uses (1) Identification. Pedicle

geometry of its articulating surfaces screw spinal systems for all other uses

and has no linkage across-the-joint. are multiple component devices, made

This generic type of device includes from a variety of materials, including

prostheses that have a talar resuralloys such as 316L stainless steel,

facing component made of alloys, such 316LVM stainless steel, 22Cr-13Ni-5Mn

as cobalt-chromium-molybdenum, and stainless steel, Ti-6Al-4V, and unal

a tibial resurfacing component made of loyed titanium, that allow the surgeon ultra-high molecular weight polyto build an implant system to fit the

ethylene and is limited to those prospatient's anatomical and physiological theses intended for use with bone cerequirements. Such an spinal implant ment (8 888.3027). assembly consists of a combination of

(b) Classification. Class II. anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms 8 888.3120 Ankle joint metal/polymer incorporating nuts, screws, sleeves, or non-constrained cemented

prosbolts; longitudinal members (e.g.,

thesis. plates, rods, and/or plate/rod combina- (a) Identification. An ankle joint tions); and/or transverse connectors. metal/polymer non-constrained (2) Classification. Class III (premarket

mented prosthesis is a device intended approval).

to be implanted to replace an ankle (c) Date PMA or notice of completion of joint. The device limits minimally (less a PDP is required. An approved PMA or

than normal anatomic constraints) a declared completed PDP must be in

translation in one or more planes. It effect before placing the device in com- has no linkage across-the-joint. This mercial distribution. See $888.3.

generic type of device includes pros[63 FR 40040, July 27, 1998]

theses that have a tibial component

made of alloys, such as cobalt-chro8 888.3100 Ankle joint metal/composite mium-molybdenum, and a talar compo

semi-constrained cemented pros- nent made of ultra-high molecular thesis.

weight polyethylene, and is limited to (a) Identification. An ankle joint those prostheses intended for use with metal/composite semi-constrained ce- bone cement (8 888.3027). mented prosthesis is a device intended (b) Classification. Class III. to be implanted to replace an ankle (c) Date PMA or notice of completion of joint. The device limits translation and a PDP is required. A PMA or a notice of rotation: in one or more planes via the completion of a PDP is required to be geometry of its articulating surfaces. filed with the Food and Drug AdminisIt has no linkage across-the-joint. This tration on or before December 26, 1996 generic type of device includes pros- for any ankle joint metal/polymer nontheses that consist of a talar resur- constrained cemented prosthesis that facing component made of alloys, such was in commercial distribution before as cobalt-chromium-molybdenum, and May 28, 1976, or that has, on or before a tibial resurfacing component fab- December 26, 1996, been found to be

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