Shoulder Innovations TSA
Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 33mm x 10°, Stainless Steel
8manufacturers in China registered for this device type
37catalogue numbers in this listing
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 | Shoulder Innovations, 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 | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K102670 |
| Record published | 2021-10-26 |
| Record revised | 2025-03-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20 mm x 8 mm | In distribution | |
| 22 mm x 10° | In distribution | |
| 27 mm x 10° | In distribution | |
| Surgical Utility Case | In distribution | |
| 22 mm x 10° | In distribution | |
| 17 mm x 52 mm | In distribution | |
| 24 mm x 8 mm | In distribution | |
| 27 mm x 8 mm | In distribution | |
| 24 mm x 5° | In distribution | |
| 15 mm x 46 mm | In distribution | |
| 21 mm x 46 mm | In distribution | |
| 10 mm x 130 mm | In distribution | |
| Surgical Utility Case Generic | In distribution | |
| 22 mm x 8 mm | In distribution | |
| 14 mm x 130 mm | In distribution | |
| 33 mm x 6 mm | In distribution | |
| 33 mm x 10° | In distribution | |
| 30 mm x 10° | In distribution | |
| 22 mm x 6 mm | In distribution | |
| 24 mm x 10° | In distribution | |
| 24 mm x 6 mm | In distribution | |
| 19 mm x 46 mm | In distribution | |
| 30 mm x 6 mm | In distribution | |
| 33 mm x 10° | In distribution | |
| 27 mm x 5° | In distribution | |
| 20 mm x 10° | In distribution | |
| 30 mm x 5° | In distribution | |
| 33 mm x 5° | In distribution | |
| 22 mm x 5° | In distribution | |
| 24 mm x 10° | In distribution | |
| 8 mm x 130 mm | In distribution | |
| 6 mm x 130 mm | In distribution | |
| 23 mm x 52 mm | In distribution | |
| 17 mm x 40 mm | In distribution | |
| 27 mm x 10° | In distribution | |
| 30 mm x 10° | In distribution | |
| 20 mm x 6 mm | In distribution |
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 |
| Arthrex® | Arthrex, Inc. | 75 |
| SMR System | Limacorporate | 72 |
| DJO Surgical | Encore Medical, L.P. | 70 |
| Humeris Shoulder | Fx Solutions | 69 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
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.