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Code · CFR · Title 21 — Food and Drugs · Part 888 — Orthopedic Devices · § 888.3500

§ 888.3500. Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.

101 words·~1 min read·/us/cfr/t21/s§ 888.3500·

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(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.
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