Arthrex®
Eclipse Titanium Humeral Head, 49 mm/18
2manufacturers in China registered for this device type
21catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Arthrex, Inc., United States |
|---|---|
| FDA product code | PKC |
| Device type | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Record published | 2021-09-21 |
| Record revised | 2025-08-25 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-9337-16T | In distribution | |
| AR-9301-37CPC | In distribution | |
| AR-9341-18T | In distribution | |
| AR-9337-16 | In distribution | |
| AR-9349-18T | In distribution | |
| AR-9355-23T | In distribution | |
| AR-9341-16T | In distribution | |
| AR-9353-22T | In distribution | |
| AR-9343-16T | In distribution | |
| AR-9351-21T | In distribution | |
| AR-9351-19T | In distribution | |
| AR-9339-18T | In distribution | |
| AR-9345-17T | In distribution | |
| AR-9353-20T | In distribution | |
| AR-9345-19T | In distribution | |
| AR-9349-20T | In distribution | |
| AR-9343-18T | In distribution | |
| AR-9355-21T | In distribution | |
| AR-9347-20T | In distribution | |
| AR-9339-16T | In distribution | |
| AR-9347-18T | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Comprehensive® Shoulder System | Biomet Orthopedics | 83 |
| Equinoxe | Exactech, Inc. | 60 |
| SMR Stemless | Limacorporate | 51 |
| Global Icon | Depuy (Ireland) | 50 |
| Sidus® Stem-Free Shoulder | Zimmer, Inc. | 39 |
| OsseoFit™ Stemless Shoulder | Zimmer, Inc. | 38 |
| DJO Surgical | Encore Medical, L.P. | 32 |
| Tornier Simpliciti® Shoulder System | Tornier Inc. | 27 |
| Simpliciti™ | Tornier Inc. | 27 |
| Tornier Perform | Tornier Inc. | 10 |
| FX V135 | Fx Solutions | 10 |
| Inhance | Depuy (Ireland) | 5 |
Showing 12 of 19. All products under Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203100 | 2020-11-20 |
| K201542 | 2020-07-08 |
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.