Aetos Shoulder System
Aetos is a shoulder replacement system that can be assembled in anatomic or reverse configurations. The anatomic arrangement uses a titanium stem, cobalt-chromium head and polyethylene…
Aetos is a shoulder replacement system that can be assembled in anatomic or reverse configurations. The anatomic arrangement uses a titanium stem, cobalt-chromium head and polyethylene glenoid component.
The reverse arrangement combines a humeral stem and polyethylene liner with a titanium glenoid baseplate, cobalt-chromium glenosphere and fixation screws. The system permits specified conversion from anatomic to reverse reconstruction.
Listed Item
10 DEG FW Augment 4 PEG Poly Glenoid M Right
Fixation by Component
The titanium-coated humeral stem is intended for uncemented use. The anatomic polyethylene glenoid is cemented. A stem and head can also form a hemiarthroplasty when the native glenoid remains suitable as the bearing surface.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Stryker Trauson (Changzhou) Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | KWS |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K220847 |
| Record published | 2023-02-09 |
| Record revised | 2025-05-23 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: : – |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SZR-0990-815-000 | In distribution | |
| MHH-0990-102-5319 | In distribution | |
| INS-0990-861 | In distribution | |
| MHH-0990-102-3814 | In distribution | |
| LNR-0990-202-386L | In distribution | |
| LNR0990-202-423LR | In distribution | |
| SPC-0990-204-L | In distribution | |
| LNR0990-200-380SR | In distribution | |
| SCW-0990-507-35 | In distribution | |
| REM-0990-865-1 | In distribution | |
| GLS0990-506-3803C | In distribution | |
| LNR0990-202-340LR | In distribution | |
| MHH-0990-102-5021 | In distribution | |
| GLN0990-403-110FL | In distribution | |
| SCW-0990-505-20 | In distribution | |
| SCW-0990-504-15 | In distribution | |
| LNR0990-200-343SR | In distribution | |
| SZR-0990-815-205 | In distribution | |
| LNR-0990-200-423S | In distribution | |
| GLN0990-403-210FR | In distribution | |
| SCW-0990-505-50 | In distribution | |
| GLN0990-403-205FR | In distribution | |
| GLS0990-506-4200C | In distribution | |
| IMP-0990-835 | In distribution | |
| SCW-0990-507-40 | In distribution | |
| GBP-0990-500-2 | In distribution | |
| MHH-0990-102-4416 | In distribution | |
| SCW-0990-504-45 | In distribution | |
| LNR0990-200-429SR | In distribution | |
| HOS-0990-805-03 | In distribution | |
| HOS-0990-805-01 | In distribution | |
| LNR-0990-200-386S | In distribution | |
| GLN0990-403-310FL | In distribution | |
| SCW-0990-505-25 | In distribution | |
| SCW-0990-504-25 | In distribution | |
| GLN0990-403-005FL | In distribution | |
| LNR-0990-202-346L | In distribution | |
| GLN0990-403-310FR | In distribution | |
| COM-0990-808-00 | In distribution | |
| LNR-0990-202-383L | In distribution | |
| SCW-0990-505-45 | In distribution | |
| LNR0990-202-386LR | In distribution | |
| LNR-0990-202-340L | In distribution | |
| SCW-0990-507-50 | In distribution | |
| LNR0990-202-389LR | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 442 |
| Reunion | Stryker GmbH | 321 |
| DJO Surgical | Encore Medical, L.P. | 266 |
| SMR Shoulder | Limacorporate | 209 |
| Tornier Flex Shoulder System | Tornier Inc. | 187 |
| Anatomical Shoulder™ | Zimmer, Inc. | 166 |
| Arthrex® | Arthrex, Inc. | 154 |
| Comprehensive Shoulder System | Biomet Orthopedics | 111 |
| Flex Shoulder System | Tornier Inc. | 109 |
| Aequalis™ PerFORM+ | Tornier Inc. | 108 |
| Aequalis™ Ascend™ Flex | Tornier Inc. | 102 |
| Anatomic Shoulder Prosthesis | Medacta International SA | 90 |
Showing 12 of 326. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254084 | 2026-04-06 |
| K252416 | 2025-10-29 |
| K230572 | 2023-06-07 |
| K220847 | 2023-01-03 |
| K213827 | 2022-03-11 |
| K113012 | 2012-01-05 |
| K030344 | 2003-03-04 |
| K012788 | 2002-03-15 |
| K012378 | 2001-12-13 |
| K003566 | 2001-02-14 |
| K994350 | 2000-05-23 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-01-14 | Not classified | Device Design | Firm received complaints of Inclination Set Screws fracturing. | 1,597 units | 2012-04-10 |
| 2010-01-14 | Not classified | Device Design | Firm received complaints of Inclination Set Screws fracturing. | 366 units | 2012-04-10 |
| 2010-01-14 | Not classified | Device Design | Firm received complaints of Inclination Set Screws fracturing. | 362 units | 2012-04-10 |
| 2010-01-14 | Not classified | Device Design | Firm received complaints of Inclination Set Screws fracturing. | 700 units | 2012-04-10 |
| 2008-11-21 | Not classified | Other | The product was breaking during use. | 159 units | 2012-11-27 |
| 2008-11-21 | Not classified | Other | The product was breaking during use. | 51 units | 2012-11-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.