---
kind: "section"
citation: "21 C.F.R. § 888.3800"
title: "21"
number: "888.3800"
heading: "Wrist joint metal/polymer semi-constrained cemented prosthesis."
url: "https://uscodex.org/cfr/21/888.3800"
---

# §888.3800. Wrist joint metal/polymer semi-constrained cemented prosthesis.

- (a) **Identification.** A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist 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 have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with 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.