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 Smith & Nephew, Inc., Arthrex, Inc. and Encore Medical, L.P..
List of Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented devices (product code KWS). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →