KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class II
FDA product code KWS covers "Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented", a Class II medical device regulated under 21 CFR 888.3660. 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
- KWS
- Device Class
- Class II
- Regulation Number
- 888.3660
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254084 | smith and nephew | AETOS Shoulder System - CONCELOC Glenoids | April 6, 2026 |
| K252418 | catalyst orthoscience | Catalyst F1x Shoulder System | November 6, 2025 |
| K252416 | smith and nephew | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | October 29, 2025 |
| K241292 | medacta international | MyShoulder Planner (5.3SSWPL) | January 30, 2025 |
| K241878 | stryker corporation (tornier, inc.) | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral Sys | December 6, 2024 |
| K241609 | stryker corporation (tornier, inc.) | Tornier Humeral Reconstruction System (Tornier HRS) | September 10, 2024 |
| K230513 | arthrex | Arthrex Univers Apex OptiFit Humeral Stem | September 26, 2023 |
| K222592 | encore medical l.p | AltiVate® Anatomic Shoulder AG e+ with Markers | June 23, 2023 |
| K230572 | smith and nephew | AETOS Shoulder System | June 7, 2023 |
| K220847 | smith and nephew | AETOS Shoulder System | January 3, 2023 |
| K222317 | catalyst orthoscience | Catalyst EA Convertible Stemmed Shoulder | November 10, 2022 |
| K213387 | encore medical l.p | AltiVate® Anatomic Shoulder AG e+ with Markers | July 7, 2022 |
| K213785 | limacorporate | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid | May 13, 2022 |
| K213827 | smith and nephew | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Hu | March 11, 2022 |
| K212356 | exactech | Exactech® Equinoxe® Laser Cage Glenoid | March 4, 2022 |
| K212435 | biomet | Comprehensive Humeral Fracture Positioning Sleeves | December 10, 2021 |
| K210861 | stryker | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty | September 3, 2021 |
| K210050 | arthrex | Augmented VaultLock Glenoid | June 7, 2021 |
| K203315 | tornier | BLUEPRINT Patient Specific Instrumentation | April 15, 2021 |
| K203230 | depuy lnc | Global Shoulder and Delta CTA systems | April 2, 2021 |