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 Biomet, Inc., Zimmer, Inc. and Catalyst Orthoscience, Inc..