21 C.F.R. § 888.3690

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

Last amended: 2016Year: 2026Length: 63 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 888.3690 (2026)

(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.
Cross-references to the CFR
888.3027
21 C.F.R. § 888.3690: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. | Justis AI