---
kind: "section"
citation: "21 C.F.R. § 888.3025"
title: "21"
number: "888.3025"
heading: "Passive tendon prosthesis."
url: "https://uscodex.org/cfr/21/888.3025"
---

# §888.3025. Passive tendon prosthesis.

- (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.

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.