21 CFR 888.3690 — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3690

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented271Implant
Innolitics

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