{"data":{"id":"us/21-cfr-888.3590","jurisdiction":"us","citation":"21 CFR 888.3590","heading":"Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.","body":"(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).\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":"f6adbbf1a1fe0ad71839d56d00334767885f4d378c05279977ac3d07081a563a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-888.3580","next":"us/21-cfr-888.3600"},"notice":"GroundRules: Original legal text. Not legal advice."}