21 CFR 888.3590
§ 888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 888.3590, § 888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91113
- Permanent ID
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83bc5ae87d52177d443a22d34cdc740d35606c014b799803e24bdaa31e699f31
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Full text
(a) Identification. A knee joint tibial (hemi-knee) metallic resurfacing uncemented 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 prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement (§ 888.3027).
(b) Classification. Class II.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.