Arthrex®
Univers II Humeral Cuff Tear Arthropathy
8manufacturers in China registered for this device type
75catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 | Arthrex, Inc., United States |
|---|---|
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Record published | 2023-08-29 |
| Record revised | 2026-02-09 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2021-07-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-9501-04-135P | In distribution | |
| AR-9548-19RCA | In distribution | |
| AR-9152-22CA | In distribution | |
| AR-9502-39ARCA | In distribution | |
| AR-9550-19RCAT | In distribution | |
| AR-9501-FX5N | In distribution | |
| AR-9522-42ARCAT | In distribution | |
| AR-9548-21RCA | In distribution | |
| AR-9501-FX5W | In distribution | |
| AR-9154-21CA | In distribution | |
| AR-9540-17RCA | In distribution | |
| AR-9501-12P | In distribution | |
| AR-9502F-39CPC | In distribution | |
| AR-9552-22RCA | In distribution | |
| AR-9501-FX6N | In distribution | |
| AR-9544-19RCA | In distribution | |
| AR-9556-22RCA | In distribution | |
| AR-9501-15P | In distribution | |
| AR-9501-09P | In distribution | |
| AR-9550-21RCA | In distribution | |
| AR-9502F-39LCPC | In distribution | |
| AR-9554-23RCA | In distribution | |
| AR-9550-19RCA | In distribution | |
| AR-9546-18RCA | In distribution | |
| AR-9501-13P | In distribution | |
| AR-9544-17RCAT | In distribution | |
| AR-9100-07M | In distribution | |
| AR-9144-19CA | In distribution | |
| AR-9502F-36RCPC | In distribution | |
| AR-9501-FX10WT | In distribution | |
| AR-9501-FX6NT | In distribution | |
| AR-9148-19CA | In distribution | |
| AR-9501-05P | In distribution | |
| AR-9100-09M | In distribution | |
| AR-9522-36ARCAT | In distribution | |
| AR-9154-23CA | In distribution | |
| AR-9501-FX6WT | In distribution | |
| AR-9150-19CA | In distribution | |
| AR-9502-36ARCA | In distribution | |
| AR-9501-FX6W | In distribution | |
| AR-9156-24CA | In distribution | |
| AR-9502F-42CPC | In distribution | |
| AR-9556-22RCAT | In distribution | |
| AR-9522-39ARCAT | In distribution | |
| AR-9552-20RCA | In distribution | |
| AR-9546-20RCA | In distribution | |
| AR-9144-17CA | In distribution | |
| AR-9501FTK | In distribution | |
| AR-9142-17CA | In distribution | |
| AR-9502F-42LCPC | In distribution | |
| AR-9501-FX10W | In distribution | |
| AR-9501-FX10N | In distribution | |
| AR-9501-08P | In distribution | |
| AR-9502F-42RCPC | In distribution | |
| AR-9556-24RCA | In distribution | |
| AR-9554-21RCA | In distribution | |
| AR-9148-21CA | In distribution | |
| AR-9501-06P | In distribution | |
| AR-9150-21CA | In distribution | |
| AR-9502-33ARCA | In distribution | |
| AR-9501-FX10NT | In distribution | |
| AR-9501-10P | In distribution | |
| AR-9156-22CA | In distribution | |
| AR-9501-14P | In distribution | |
| AR-9544-19RCAT | In distribution | |
| AR-9544-17RCA | In distribution | |
| AR-9501-11P | In distribution | |
| AR-9152-20CA | In distribution | |
| AR-9501-07P | In distribution | |
| AR-9146-20CA | In distribution | |
| AR-9502RSC | In distribution | |
| AR-9100-12M | In distribution | |
| AR-9502-42ARCA | In distribution | |
| AR-9146-18CA | In distribution | |
| RAR-9200CAI | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 345 |
| SMR Shoulder | Limacorporate | 182 |
| FX V135 | Fx Shoulder Solutions SAS | 127 |
| Acumed | Acumed LLC | 112 |
| Promos | Smith & Nephew, Inc. | 104 |
| Trabecular Metal® | Zimmer, Inc. | 90 |
| Bigliani/Flatow® | Zimmer, Inc. | 86 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 85 |
| SMR System | Limacorporate | 72 |
| DJO Surgical | Encore Medical, L.P. | 70 |
| Humeris Shoulder | Fx Solutions | 69 |
| Prima | Limacorporate | 67 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233260 | 2024-02-12 |
| K221232 | 2022-05-19 |
| K161782 | 2016-11-21 |
| K151527 | 2016-04-19 |
| K130675 | 2013-10-30 |
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.