eCFR Reference Browser

---

title: "21 CFR §888.3810"

source: "https://www.ecfr.gov/current/title-21/section-888.3810"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "888"

part_subject: "ORTHOPEDIC DEVICES"

subpart_code: "D"

subpart_subject: "Prosthetic Devices"

section_number: "888.3810"

section_subject: "Wrist joint ulnar (hemi-wrist) polymer prosthesis."

cfr_reference: "21 CFR 888.3810"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

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