21 C.F.R. § 888.3230
Finger joint polymer constrained prosthesis.
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.