---
kind: "section"
citation: "21 C.F.R. § 888.3720"
title: "21"
number: "888.3720"
heading: "Toe joint polymer constrained prosthesis."
url: "https://uscodex.org/cfr/21/888.3720"
---

# §888.3720. Toe joint polymer constrained prosthesis.

- (a) **Identification.** A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.
- (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.