21 CFR 888.3680 — Metallic Cemented Glenoid Hemi-Shoulder Prosthesis

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3680

Identification

A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component made of alloys, such as cobalt-chromium-molybdenum, or alloys with ultra-high molecular weight polyethylene and intended to be implanted to replace part of a shoulder joint. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Classification Rationale

Class III.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KYMMetallic Cemented Glenoid Hemi-Shoulder Prosthesis30Implant
Innolitics

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