TriFit TS Blade Stem
TriFit TS Tapered Stem Lateralised Size 9
10manufacturers in China registered for this device type
30catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| 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 | Corin Limited, United Kingdom |
|---|---|
| FDA product code | KWL |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K121563 |
| Record published | 2019-03-27 |
| Record revised | 2024-09-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6950885 | In distribution | |
| 694.1009 | In distribution | |
| 695.570 | In distribution | |
| 694.0007 | In distribution | |
| 694.1007 | In distribution | |
| 695.1010 | In distribution | |
| 695.301 | In distribution | |
| 694.0005 | In distribution | |
| 694.1004 | In distribution | |
| 695.460 | In distribution | |
| 694.1005 | In distribution | |
| 694.0001 | In distribution | |
| 695.571 | In distribution | |
| 3999322 | In distribution | |
| 6950550 | In distribution | |
| 3990767 | In distribution | |
| 695.954 | In distribution | |
| A399.9740 | In distribution | |
| 3990880 | In distribution | |
| 695.465 | In distribution | |
| 694.0011 | In distribution | |
| 695.1100 | In distribution | |
| 6950880 | In distribution | |
| 695.955 | In distribution | |
| 6950440 | In distribution | |
| 695.260 | In distribution | |
| 694.0006 | In distribution | |
| 695.1060 | In distribution | |
| Z399.9750 | In distribution | |
| 695.1090 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ustar II Knee System | United Orthopedic Corp. | 115 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 95 |
| Consensus® Hip System | Consensus Orthopedics, Inc. | 95 |
| Instrument | Howmedica Osteonics Corp | 94 |
| UHR | Howmedica Osteonics Corp | 75 |
| Austin Moore | Howmedica Osteonics Corp | 67 |
| B-P Total HIP System | Endotec, Inc. | 66 |
| CS2 Acetabular Cup System | Consensus Orthopedics, Inc. | 64 |
| DJO Surgical | Encore Medical, L.P. | 62 |
| Restoration | Howmedica Osteonics Corp | 56 |
| Optimom Modular Heads | Corin Limited | 49 |
| Corin Unipolar Modular Head | Corin Limited | 36 |
Showing 12 of 167. All products under Prosthesis, Hip, Hemi-, Femoral, Metal
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Corin Limited | 510(k) number | 2021-07-28 | Class II | Storage | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. | 5 | 2024-06-12 |
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.