{"data":{"id":"us/21-cfr-888.3025","jurisdiction":"us","citation":"21 CFR 888.3025","heading":"Passive tendon prosthesis.","body":"(a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a polyester reinforced medical grade silicone elastomer intended for use in the surgical reconstruction of a flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for the ligament or tendon nor to function as a scaffold for soft tissue ingrowth.\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":"d1e4784032b2f55dd275a2044caf52109fde6bee930eab2b1f63fff137808f38","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-888.3023","next":"us/21-cfr-888.3027"},"notice":"GroundRules: Original legal text. Not legal advice."}