21 CFR 888.3370 — Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3370

Identification

A hip joint (hemi-hip) acetabular metal cemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have an acetabular component made of alloys, such as cobalt-chromium-molybdenum. 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
KWBProsthesis, Hip, Hemi-, Acetabular, Cemented, Metal30Implant
Innolitics

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