KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class II
FDA Device Classification
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 |
|---|
| 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 |
| K203026 | encore medical, l.p | AltiVate® Anatomic Pegged Glenoid with Markers | December 23, 2020 |