21 C.F.R. § 888.3500

Current through October 31, 2024
Section 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis
(a)Identification. A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a two-part device 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component with the articulating surfaces made of ultra-high molecular weight polyethylene with carbon-fibers composite and is limited to those prostheses intended for use with bone cement (§ 888.3027 ).
(b)Classification. Class II.

21 C.F.R. §888.3500