Title 21

SECTION 888.3550

888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.

§ 888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.

(a) Identification. A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component, a tibial component, a cylindrical bolt and accompanying locking hardware that are all made of alloys, such as cobalt-chromium-molybdenum, and a 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]

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