21 CFR 888.3580 — Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3580

Identification

A knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum, intended to be implanted to replace the retropatellar articular surface of the patellofemoral joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a retropatellar resurfacing component and an orthopedic screw to transfix the patellar remnant. This generic type of device is limited to those prostheses intended for use without bone cement (§ 888.3027).

Classification Rationale

(1) Class II when intended for treatment of degenerative and posttraumatic patellar arthritis.(2) Class III when intended for uses other than treatment of degenerative and posttraumatic patellar arthritis.

Product Codes