888.3570—Knee joint femoral (hemi-knee) 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 ).
(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.