{"data":{"id":"us/21-cfr-888.3000","jurisdiction":"us","citation":"21 CFR 888.3000","heading":"Bone cap.","body":"(a) Identification. A bone cap is a mushroom-shaped device intended to be implanted made of either silicone elastomer or ultra-high molecular weight polyethylene. It is used to cover the severed end of a long bone, such as the humerus or tibia, to control bone overgrowth in juvenile amputees.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.","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":"c984bdb3701c9dbdc83939f0d95321432730880f20a105c5c6ad9e89ef126811","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-888.1600","next":"us/21-cfr-888.3010"},"notice":"GroundRules: Original legal text. Not legal advice."}