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Code · CFR · Title 21 — Food and Drugs · Part 888 — Orthopedic Devices · § 888.3100

§ 888.3100. Ankle joint metal/composite semi-constrained cemented prosthesis.

97 words·~1 min read·/us/cfr/t21/s§ 888.3100·

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(a)Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle 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 consist of a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component fabricated from 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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