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

---
identifier: "/us/cfr/t21/s888.3810"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 888.3810 - Wrist joint ulnar (hemi-wrist) polymer prosthesis."
title_number: 21
title_name: "Food and Drugs"
section_number: "888.3810"
section_name: "Wrist joint ulnar (hemi-wrist) polymer prosthesis."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "888"
part_name: "ORTHOPEDIC DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "52 FR 33702, Sept. 4, 1987, unless otherwise noted."
cfr_part: "888"
---


# 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.