Shoulder Innovations TSA System
Instrument. Anatomic Sizer Disk Handle - 5 and 10 degree
6manufacturers in China registered for this device type
35catalogue 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 |
| Record published | 2018-06-30 |
| Record revised | 2023-05-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HUMERAL STEM TRIAL 10MM X 130MM | In distribution | |
| Anatomic Sizer Disk Handle – 5 and 10 degree | In distribution | |
| Glenoid Reamer Assembly – 20MM | In distribution | |
| Glenoid Reamer Assembly – 30MM | In distribution | |
| Anatomic Sizer Disk – 24mm | In distribution | |
| HUMERAL HEAD TRIAL 19MM X 52MM | In distribution | |
| Glenoid Reamer Assembly – 24MM | In distribution | |
| Glenoid Driver Grip | In distribution | |
| HUMERAL MULTI PURPOSE TOOL | In distribution | |
| Peripheral Drill Guide 24mm | In distribution | |
| Glenoid Reamer Assembly – 22MM | In distribution | |
| Anatomic Sizer Disk Handle – 0 degree | In distribution | |
| Glenoid Reamer Assembly – 27MM | In distribution | |
| GLENOID TRIAL 30MM X 6MM | In distribution | |
| Sizer Disk 22 + 24mm | In distribution | |
| REAMER/DRILL 22MM | In distribution | |
| Anatomic Sizer Disk – 27mm | In distribution | |
| SIZER DISK 27 + 30 | In distribution | |
| Peripherla Drill Guide 30mm | In distribution | |
| Peripheral Drill 5mm | In distribution | |
| HUMERAL HEAD TRIAL 21MM X 46MM | In distribution | |
| Anatomic Sizer Disk – 20mm | In distribution | |
| Cannulated Central Drill 6.5mm | In distribution | |
| Peripheral Drill Guide 27mm | In distribution | |
| Center Drill | In distribution | |
| REAMER/DRILL 20MM | In distribution | |
| REAMER/DRILL 22MM | In distribution | |
| HUMERAL STEM TRIAL 6MM X 130MM | In distribution | |
| 1mm Reamer Stop | In distribution | |
| Anatomic Sizer Disk – 22mm | In distribution | |
| Anatomic Sizer Disk – 30mm | In distribution | |
| Glenoid Reamer Assembly – 24MM | In distribution | |
| ANTI ROTATION PEG | In distribution | |
| Center Drill Cannulated | In distribution | |
| CANAL REAMER 14MM | 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.