(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 Administration on or before December 26, 1996 for any hip joint (hemi-hip) acetabular metal 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 hip joint (hemihip) 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 completed PDP in effect before being placed in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996]

§ 888.3380 Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.

(a) Identification. A hip joint femoral (hemi-hip) trunnion-bearing metal/ polyacetal cemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that consist of a metallic stem made of alloys, such as cobalt-chromium-molybdenum, with

an integrated cylindrical trunnion bearing at the upper end of the stem that fits into a recess in the head of the device. The head of the device is

made of polyacetal (polyoxymethylene) and it is covered by a metallic alloy, such as cobalt-chromium-molybdenum. The trunnion bearing allows the head of the device to rotate on its stem. The prosthesis is intended for use with 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 Administration on or before December 26, 1996 for any hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal 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 hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis that was in commercial distribution before May 28, 1976. Any other hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[52 FR 33702, Sept. 4. 1987, as amended at 61 FR 50710, Sept. 27, 1996]

(a) Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobaltchromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.

(b) Classification. Class II.

§ 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

(a) Identification. A hip joint femoral (hemi-hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip

(a) Identification. A hip joint metal/ polymer semi-constrained resurfacing cemented prosthesis is a two-part device intended to be implanted to replace the articulating surfaces of the hip while preserving the femoral head and neck. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-thejoint. This generic type of device includes prostheses that consist of a femoral cap component made of alloy, such as cobalt-chromium-molybdenum, that is placed over a surgically prepared femoral head, and an acetabular resurfacing polymer component. Both components are intended for use with bone cement (§ 888.3027).

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 888.3.

§ 888.3480 Knee joint femorotibial metallic constrained cemented prosthesis.

(a) Identification. A knee joint femorotibial metallic constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. The only knee joint movement allowed by the device is in the sagittal plane. This generic type of device includes prostheses that have an intramedullary stem at both the proximal and distal locations. The upper and lower components may be joined either by a solid bolt or pin, an internally threaded bolt with locking screw, or a bolt retained by circlip. The components of the device are made of alloys, such as cobalt-chromium-molybdenum. The stems of the device may be perforated, but are intended for use with 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 Administration on or before December 26, 1996 for any knee joint femorotibial metallic constrained 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 femorotibial metallic constrained cemented prosthesis that was in commercial distribution before May 28, 1976. Any other knee joint femorotibial metallic constrained cemented prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996]

§888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis.

(a) Identification. A knee joint femorotibial metal/composite non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial condylar component or components made of ultra-high molecular weight polyethylene with carbon fibers composite and are intended for use with bone cement (§ 888.3027). (b) Classification. Class II.

§ 888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.

(a) Identification. A knee joint femorotibial metal/composite semiconstrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This

generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component with the articulating surfaces made of ultra-high molecular weight polyethylene with carbon-fibers composite and is limited to those prostheses intended for use with bone cement (§ 888.3027).

(b) Classification. Class II.

§888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

con

de

(a) Identification. A knee joint femorotibial metal/polymer strained cemented prosthesis is a vice intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that pressfit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the

transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

(b) Classification. Class II.

§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027). (b) Classification. Class II.

§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

(a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes 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 made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultrahigh molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

(b) Classification. Class II.

§ 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

(a) Identification. Α knee joint patellofemoral polymer/metal semiconstrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary

patellofemoral

chondromalacia.

arthritis or The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (§ 888.3027). The patellar component is designed to be implanted only with its femoral component.

(b) Classification. 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 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 Bone or Bone Cement,"

(iv) "Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices," and

(v) "Guidance Document for Testing Non-articulating, 'Mechanically Locked' Modular Implant Components," and

(2) International Organization for Standardization's (ISO):

(i) ISO 5832-3:1996 "Implants for Surgery-Metallic Materials-Part

Wrought Titanium 6-Aluminum

Vandium Alloy,"

3:

4

(ii) ISO 5832-4:1996 "Implants for Surgery-Metallic Materials-Part 4: CoCasting

balt-Chromium-Molybdenum

Alloy,"

(iii) 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,"

(v) 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, Packaging, and Labeling,”

(vii) ISO 7207-2:1998 "Implants for Surgery-Components for Partial and Total Knee Joint Prostheses-Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials," and

(viii) ISO 9001:1994 "Quality Systems-Model for Quality Assurance in Design/Development, Production, Installation, and Servicing," and

(3) American Society for Testing and Materials':

(i) F 75-92 "Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,"

(ii) F 648-98 "Specification for UltraHigh-Molecular-Weight Polyethylene Powder and Fabricated Form 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 Porous Metal Coatings,"

(v) F 1108-97 "Titanium-6 Aluminum4 Vanadium Alloy Castings for Surgical Implants,"

a

component, a cylindrical bolt and accompanying locking hardware that are all made of alloys, such as cobalt-chromium-molybdenum, and retropatellar resurfacing component made of ultra-high molecular weight polyethylene. The retropatellar surfacing component may be attached to the resected patella either with a metallic screw or bone cement. All stemmed metallic components within this generic type are intended for use with 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 Administration on or before December 26, 1996 for any knee joint patellofemorotibial polymer/metal/metal constrained 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 constrained cemented prosthesis that was in commercial distribution before May 28, 1976. Any other knee

joint

patellofemorotibial polymer/metal/ metal constrained cemented prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996]

§ 888.3560 Knee

(a)

joint patellofemorotibial polymer/metal/ polymer semi-constrained cemented prosthesis.

Identification. A knee joint patellofemorotibial polymer/metal/ polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic

type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

(b) Classification. Class II.

§ 888.3570 Knee joint femoral (hemiknee) metallic uncemented prosthesis.

(a) Identification. A knee joint femoral (hemi-knee) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum, intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes 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 fixation and is limited to those prostheses intended for use without 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 Administration on or before December 26, 1996 for any knee joint femoral (hemi-knee) metallic uncemented 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 femoral (hemi-knee) metallic uncemented prosthesis that was in commercial distribution before May 28, 1976. Any other knee joint femoral (hemi-knee) metallic uncemented prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996]

§ 888.3580 Knee joint patellar (hemiknee) metallic resurfacing uncemented prosthesis.

(a) Identification. Α knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis is a device made of alloys, such as cobaltchromium-molybdenum, intended to be implanted to replace the retropatellar articular surface of the patellofemoral joint. The device limits minimally (less