21 C.F.R. § 888.3490

Current through May 31, 2024
Section 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.

21 C.F.R. §888.3490