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..
FDA 510(k) Cleared Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented Devices (Product Code KWS)
About Product Code KWS - Regulatory Context
510(k) Submission Activity
190 total 510(k) submissions under product code KWS since 1980, with 190 receiving FDA clearance (average review time: 117 days).
Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.
FDA Review Time
Recent submissions under KWS have taken an average of 137 days to reach a decision - up from 116 days historically. Manufacturers should account for longer review timelines in current project planning.
KWS devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →