{"data":{"id":"us/21-cfr-888.3810","jurisdiction":"us","citation":"21 CFR 888.3810","heading":"Wrist joint ulnar (hemi-wrist) polymer prosthesis.","body":"(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.\n(b) Classification. Class II.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 888—ORTHOPEDIC DEVICES","Subpart D—Prosthetic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"b81f70baae63694e6115c359da9a8e28b2816afe4ccce583ee13868fbb1d7d1a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-888.3800","next":"us/21-cfr-888.4150"},"notice":"GroundRules: Original legal text. Not legal advice."}