AETOS Shoulder System Stemless Humeral Prosthesis
FDA 510(k) clearance K252129 · decided 2025-10-03
Clearance details
- K-number
- K252129
- Device name
- AETOS Shoulder System Stemless Humeral Prosthesis
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-07-07
- Decision date
- 2025-10-03
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- PKC
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Cordova, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FX V135 EASYTECH® Shoulder System (K254154) | FX Shoulder Solutions, Inc. | 2026-05-01 |
| INHANCE INTACT™ (K243248) | Depuy Ireland UC | 2024-12-23 |
| OsseoFit Stemless Shoulder System (K241873) | Zimmer, Inc. | 2024-12-11 |
| AETOS Shoulder System Stemless Humeral Prosthesis (K240716) | Smith & Nephew, Inc. | 2024-11-20 |
| SMR Stemless Anatomic (K221758) | Lima Corporate S.P.A. | 2023-03-17 |
| Tornier Perform Humeral System – Stemless (K220418) | Tornier, Inc. | 2022-09-14 |
| Shoulder Innovations Total Shoulder System (K213615) | Shoulder Innovations, Inc. | 2022-03-11 |
| GLOBAL ICON Stemless Shoulder System (K212683) | Depuy(Ireland) | 2022-01-19 |
| Ignite Stemless Anatomic Shoulder System (K203108) | Ignite Orthopedics, LLC | 2021-07-16 |
| Easytech® Anatomical Shoulder System (K201391) | Fx Shoulder USA, Inc. | 2021-02-16 |
| Arthrex Eclipse Titanium Humeral Head (K203100) | Arthrex, Inc. | 2020-11-20 |
| Arthrex Eclipse Shoulder Prosthesis System (K201542) | Arthrex, Inc. | 2020-07-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |