21 CFR § 888.3810 Orthopedic Devices

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

Current through Sep 8, 2026 · Read all of Part 888

(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.

← § 888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.§ 888.4150 Calipers for clinical use. →