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§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.

21 CFR 888.3810

Citation21 CFR 888.3810
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.

(a) Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.

(b) Classification. Class II.