510(k) K230572
- Device
- AETOS Shoulder System
- Applicant
- Smith & Nephew, Inc.
- 510(k) number
- K230572
- Product code
- KWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-07
- Date received
- 2023-03-01
- Regulation
- 888.3660
- Classification name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Patrick Hughes
- Address
- 7135 Goodlett Farms Pkwy. Cordova TN US 38016 38016
FDA Registration Numbers
- 3003403260
- 1423662
- 1450662
- 1000200989
- 3027484613
- 1833506
- 1422572
- 3004641308
- 3005180920
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- 2528981
- 9616671
- 3010375065
- 1529009
- 3004983210
- 3006984710
- 3014302784
- 3010898856
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00885556814390 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-06-21 |
| 00885556871706 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-06-19 |
| 00885556871690 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-06-19 |
| 00885556871683 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-06-19 |
| 00885556871669 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-06-19 |
| 00885556811603 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-06-19 |
| 00885556811597 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-06-19 |
Other 510(k) Records For Product Code KWS
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | 2026-04-06 |
| K252418 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2025-11-06 |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | 2025-10-29 |
| K241292 | MyShoulder Planner (5.3SSWPL) | Medacta International S.A. | 2025-01-30 |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) | Stryker Corporation (Tornier, Inc.) | 2024-12-06 |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS) | Stryker Corporation (Tornier, Inc.) | 2024-09-10 |
| K230513 | Arthrex Univers Apex OptiFit Humeral Stem | Arthrex, Inc. | 2023-09-26 |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with Markers | Encore Medical L.P. | 2023-06-23 |
| K220847 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-01-03 |
| K222317 | Catalyst EA Convertible Stemmed Shoulder | Catalyst Orthoscience, Inc. | 2022-11-10 |
| K213387 | AltiVate® Anatomic Shoulder AG e+ with Markers | Encore Medical L.P. | 2022-07-07 |
| K213785 | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid | Limacorporate | 2022-05-13 |
| K213827 | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) | Smith & Nephew, Inc. | 2022-03-11 |
| K212356 | Exactech® Equinoxe® Laser Cage Glenoid | Exactech, Inc. | 2022-03-04 |
| K212435 | Comprehensive Humeral Fracture Positioning Sleeves | Biomet, Inc. | 2021-12-10 |