21 CFR § 888.3590 Orthopedic Devices

§ 888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

Current through Sep 8, 2026 · Read all of Part 888

(a) Identification. A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement (§ 888.3027).

(b) Classification. Class II.

← § 888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.§ 888.3600 Implantable post-surgical kinematic measurement knee device. →