eCFR Reference Browser

---

title: "21 CFR §888.3690"

source: "https://www.ecfr.gov/current/title-21/section-888.3690"

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: "888.3690"

section_subject: "Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis."

cfr_reference: "21 CFR 888.3690"

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 shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.

(b)Classification. Class II.

§888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.