FDA Product Code KWT: Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Under FDA product code KWT, non-constrained shoulder prostheses with metal and polymer bearing surfaces are cleared for shoulder hemiarthroplasty and total arthroplasty.
Non-constrained designs rely on intact rotator cuff function and soft tissue balance for joint stability rather than mechanical constraint. They are indicated in patients with preserved rotator cuff integrity and normal glenoid bone stock.
KWT devices are Class II medical devices, regulated under 21 CFR 888.3650 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Waldemar Link GmbH & Co. KG, Exactech, Inc. and Tornier, Inc..
List of Prosthesis, Shoulder, Non-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, Non-constrained, Metal/polymer Cemented devices (product code KWT). 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 →