21 C.F.R. § 888.3520

Current through November 30, 2024
Section 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.

21 C.F.R. §888.3520