§ 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.