21 C.F.R. § 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart D—Prosthetic Devices
§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
