21 C.F.R. § 888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart D—Prosthetic Devices
§ 888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
