KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Class II
FDA product code KWT covers "Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented", a Class II medical device regulated under 21 CFR 888.3650. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KWT
- Device Class
- Class II
- Regulation Number
- 888.3650
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250713 | exactech | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implant | December 1, 2025 |
| K251686 | tornier | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | October 30, 2025 |
| K241944 | implantcast | AGILON® XO Shoulder Replacement System | March 10, 2025 |
| K241817 | shoulder innovations | InSet Total Shoulder System | February 11, 2025 |
| K231657 | implantcast | AGILON® XO Shoulder Replacement System | February 16, 2024 |
| K223631 | biomet orthopedics | Comprehensive Segmental Revision System(SRS) | July 12, 2023 |
| K222482 | implantcast | AGILON XO Shoulder System | September 28, 2022 |
| K210899 | waldemar link gmbh and co. kg | LINK Embrace Shoulder System- Anatomical Configuration | June 21, 2021 |
| K191698 | fx shoulder usa | TiN Coated Humeral Head | July 16, 2020 |
| K192365 | shoulder innovations | Shoulder Innovations Total Shoulder System | November 29, 2019 |
| K191811 | catalyst orthoscience | Catalyst OrthoScience CSR Shoulder System | September 11, 2019 |
| K190595 | orthosoft inc (d/b/a zimmer cas) | Signature ONE System | June 5, 2019 |
| K182500 | catalyst orthoscience | Catalyst CSR Press-Fit Humeral Components | January 11, 2019 |
| K181287 | catalyst orthoscience | Catalyst CSR Shoulder System | July 12, 2018 |
| K173812 | catalyst orthoscience | Catalyst CSR 3 Peg Glenoids | March 9, 2018 |
| K162903 | exactech | Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies | February 27, 2017 |
| K161476 | lima corporate | SMR Shoulder System | June 24, 2016 |
| K152825 | catalyst orthoscience | Catalyst CSR Shoulder System | May 11, 2016 |
| K150730 | zimmer | Zimmer PSI Shoulder System | June 16, 2015 |
| K143659 | exactech | Equinoxe Mega Prosthesis | April 9, 2015 |