21 CFR 888.3530
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 888.3530, § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91105
- Permanent ID
ys:prov:91105@1- SHA-256
58e463d2081cd168644b09952653ca6661b1b51fbee586876425c9b0d3e81713
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with 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.