Code of Federal Regulations Title 21. Food and Drugs § 21.888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis

(a) Identification. A knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum, intended to be implanted to replace the retropatellar articular surface of the patellofemoral 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 retropatellar resurfacing component and an orthopedic screw to transfix the patellar remnant. This generic type of device is limited to those prostheses intended for use without bone cement (§ 888.3027).

(b) Classification.

(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 patellar (hemi-knee) metallic resurfacing uncemented prosthesis described in paragraph (b)(2) of this section 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 patellar (hemi-knee) metallic resurfacing uncemented prosthesis that was in commercial distribution before May 28, 1976. Any other knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.