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Code · CFR · Title 21 — Food and Drugs · Part 888 — Orthopedic Devices · § 888.3520

§ 888.3520. Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

92 words·~1 min read·/us/cfr/t21/s§ 888.3520·

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(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.
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