21 CFR § 888.3780 Orthopedic Devices

§ 888.3780 Wrist joint polymer constrained prosthesis.

Current through Sep 8, 2026 · Read all of Part 888

(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.

← § 888.3770 Wrist joint carpal trapezium polymer prosthesis.§ 888.3790 Wrist joint metal constrained cemented prosthesis. →