21 C.F.R. § 888.3720

Current through November 30, 2024
Section 888.3720 - Toe joint polymer constrained prosthesis
(a)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.
(b)Classification. Class II.

21 C.F.R. §888.3720