FDA Product Code KWS: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

Under FDA product code KWS, semi-constrained shoulder prostheses with metal and polymer bearing surfaces are cleared for total shoulder arthroplasty.

These anatomical shoulder replacement systems reproduce the natural ball-and-socket geometry of the glenohumeral joint, with a metal humeral head articulating against a polymer glenoid component. They are indicated for patients with intact or repairable rotator cuff function.

KWS devices are Class II medical devices, regulated under 21 CFR 888.3660 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Arthrex, Inc., Tornier, Inc. and Tornier.