eCFR Reference Browser

---

title: "21 CFR §888.3025"

source: "https://www.ecfr.gov/current/title-21/section-888.3025"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "888"

part_subject: "ORTHOPEDIC DEVICES"

subpart_code: "D"

subpart_subject: "Prosthetic Devices"

section_number: "888.3025"

section_subject: "Passive tendon prosthesis."

cfr_reference: "21 CFR 888.3025"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

(b)Classification. Class II.

§888.3025 - Passive tendon prosthesis.