21 CFR 888.3720 — Prosthesis, Toe, Constrained, Polymer

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3720

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KWHProsthesis, Toe, Constrained, Polymer221Implant
Innolitics

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