21 C.F.R. § 888.3230

Finger joint polymer constrained prosthesis.

Last amended: 2016Year: 2026Length: 69 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 888.3230 (2026)

(a) Identification. A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve. (b) Classification. Class II.
21 C.F.R. § 888.3230: Finger joint polymer constrained prosthesis. | Justis AI