Shoulder Innovations TSA
Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 22mm x 10°, Stainless Steel
6manufacturers in China registered for this device type
21catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Shoulder Innovations, Inc, United States |
|---|---|
| FDA product code | KWT |
| Device type | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3650 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K102670 |
| Record published | 2019-11-01 |
| 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 |
|---|---|---|
| 22 mm x 5° | In distribution | |
| 24 mm x 5° | In distribution | |
| 33 mm x 10° | In distribution | |
| 24 mm x 5° | In distribution | |
| 33 mm x 5° | In distribution | |
| 20 mm x 10° | In distribution | |
| 30 mm x 5° | In distribution | |
| 17 mm x 46 mm | In distribution | |
| 20 mm x 5° | In distribution | |
| 27 mm x 5° | In distribution | |
| 20 mm x 5° | In distribution | |
| 5mm Peripheral Drill | In distribution | |
| 27 mm x 5° | In distribution | |
| 19 mm x 52 mm | In distribution | |
| 27 mm x 10° | In distribution | |
| 22 mm x 5° | In distribution | |
| 22 mm x 10° | In distribution | |
| 30 mm x 10° | In distribution | |
| 30 mm x 5° | In distribution | |
| 24 mm x 10° | In distribution | |
| 33 mm x 5° | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 336 |
| SMR Shoulder | Limacorporate | 289 |
| Tornier Perform Humeral System | Tornier Inc. | 119 |
| Bigliani/Flatow® | Zimmer, Inc. | 119 |
| Trabecular Metal® | Zimmer, Inc. | 115 |
| Jarvis Glenoid Rerverse Shoulder Prosthesis | Fournitures Hospitalieres Industrie | 103 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 86 |
| Alliance® | Zimmer, Inc. | 68 |
| Anatomical Shoulder™ | Zimmer, Inc. | 54 |
| Aetos Shoulder System | Smith & Nephew, Inc. | 53 |
| Perform™ Humeral System | Tornier Inc. | 47 |
| Bio-Modular® Shoulder System | Biomet Orthopedics | 43 |
Showing 12 of 164. All products under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241817 | 2025-02-11 |
| K192365 | 2019-11-29 |
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.