KWT
- Product code
- KWT
- Device name
- Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3650
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 71
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250713 | 2025-12-01 | Exactech, Inc. | Equinoxe® Humeral Reconstruction Prosthesis; Equinox | |
| K251686 | 2025-10-30 | Tornier, Inc. | Tornier Humeral Reconstruction System Max (Tornier H | |
| K241944 | 2025-03-10 | Implantcast GmbH | AGILON® XO Shoulder Replacement System | |
| K241817 | 2025-02-11 | Shoulder Innovations, Inc. | InSet Total Shoulder System | |
| K231657 | 2024-02-16 | Implantcast GmbH | AGILON® XO Shoulder Replacement System |
Official FDA classification page: KWT
Classification and pathway per current FDA publications. Data from openFDA (CC0).