21 CFR § 888.3230 Orthopedic Devices

§ 888.3230 Finger joint polymer constrained prosthesis.

Current through Sep 8, 2026 · Read all of Part 888

(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.

← § 888.3220 Finger joint metal/polymer constrained cemented prosthesis.§ 888.3300 Hip joint metal constrained cemented or uncemented prosthesis. →