---
kind: "section"
citation: "21 C.F.R. § 888.3690"
title: "21"
number: "888.3690"
heading: "Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis."
url: "https://uscodex.org/cfr/21/888.3690"
---

# §888.3690. Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

- (a) **Identification.** A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement ([§ 888.3027](/cfr/21/888.3027.md)). This device is not intended for biological fixation.
- (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.