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 Implantcast GmbH, Shoulder Innovations, Inc. and Exactech, Inc..
FDA 510(k) Cleared Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented Devices (Product Code KWT)
About Product Code KWT - Regulatory Context
510(k) Submission Activity
71 total 510(k) submissions under product code KWT since 1979, with 71 receiving FDA clearance (average review time: 131 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under KWT have taken an average of 225 days to reach a decision - up from 126 days historically. Manufacturers should account for longer review timelines in current project planning.
KWT devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →