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

---
identifier: "/us/cfr/t21/s888.3690"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis."
title_number: 21
title_name: "Food and Drugs"
section_number: "888.3690"
section_name: "Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "888"
part_name: "ORTHOPEDIC DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "52 FR 33702, Sept. 4, 1987, unless otherwise noted."
cfr_part: "888"
---


# 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). This device is not intended for biological fixation.

(b) *Classification.* Class II.