KWS
- Product code
- KWS
- Device name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3660
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 8 (direct download)
- 510(k) clearances (all years, FDA)
- 191 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260721 | 2026-07-22 | Tornier, Inc. | Tornier Perform Advanced Glenoid | |
| K254084 | 2026-04-06 | Smith & Nephew, Inc. | AETOS Shoulder System - CONCELOC Glenoids | |
| K252418 | 2025-11-06 | Catalyst Orthoscience, Inc. | Catalyst F1x Shoulder System | |
| K252416 | 2025-10-29 | Smith & Nephew, Inc. | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | |
| K241292 | 2025-01-30 | Medacta International S.A. | MyShoulder Planner (5.3SSWPL) | |
| K241878 | 2024-12-06 | Stryker Corporation (Tornier, Inc.) | Tornier Humeral Reconstruction System (Tornier HRS);… | |
| K241609 | 2024-09-10 | Stryker Corporation (Tornier, Inc.) | Tornier Humeral Reconstruction System (Tornier HRS) | |
| K230513 | 2023-09-26 | Arthrex, Inc. | Arthrex Univers Apex OptiFit Humeral Stem |
Official FDA classification page: KWS
Classification and pathway per current FDA publications. Data from openFDA (CC0).