GroundRules
21 CFR 888.3490: Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 888—ORTHOPEDIC DEVICES
- Subpart D—Prosthetic Devices
(a) Identification. A knee joint femorotibial metal/composite non-constrained cemented 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 generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial condylar component or components made of ultra-high molecular weight polyethylene with carbon fibers composite and are intended for use with bone cement (§ 888.3027).
(b) Classification. Class II.
Collected 2026-08-27T02:24:47Z. Source file · JSON