View all text of Subpart D [§ 888.3000 - § 888.3810]

§ 888.3780 - Wrist joint polymer constrained prosthesis.

(a) Identification. A wrist joint polymer constrained prosthesis is a device made of polyester-reinforced silicone elastomer intended to be implanted to replace a wrist 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.