---
kind: "section"
citation: "21 C.F.R. § 888.3590"
title: "21"
number: "888.3590"
heading: "Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis."
url: "https://uscodex.org/cfr/21/888.3590"
---

# §888.3590. Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

- (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](/cfr/21/888.3027.md)).
- (b) **Classification.** Class II.

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.