21 CFR 888.3230 — Prosthesis, Finger, Polymer

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3230

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KWFProsthesis, Finger, Polymer20Implant
KYJProsthesis, Finger, Constrained, Polymer214Implant
Innolitics

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