{"data":{"id":"us/21-cfr-888.3500","jurisdiction":"us","citation":"21 CFR 888.3500","heading":"Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.","body":"(a) Identification. A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component with the articulating surfaces made of ultra-high molecular weight polyethylene with carbon-fibers composite and is limited to those prostheses intended for use with bone cement (§ 888.3027).\n(b) Classification. Class II.","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"15d7f0caf2fa50da6a06a781e01185216bf12cdf18174dab97511cf85c078941","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-888.3490","next":"us/21-cfr-888.3510"},"notice":"GroundRules: Original legal text. Not legal advice."}