21 CFR 888.3550 — Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3550

Identification

A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component, a tibial component, a cylindrical bolt and accompanying locking hardware that are all made of alloys, such as cobalt-chromium-molybdenum, and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. The retropatellar surfacing component may be attached to the resected patella either with a metallic screw or bone cement. All stemmed metallic components within this generic type are intended for use with bone cement (§ 888.3027).

Classification Rationale

Class III.

Product Codes