Trinity Acetabular Hip System
Trinity CoCr Modular Head Ø28mm SHORT -3.5mm 12/14 Eurocone Taper
9manufacturers in China registered for this device type
58catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 | LWJ |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K093472 |
| Record published | 2016-08-17 |
| Record revised | 2020-12-21 (version 6) |
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 |
|---|---|---|
| 921.03.632 | In distribution | |
| 321.03.028 | In distribution | |
| 921.100 | In distribution | |
| 921.205 | In distribution | |
| 921.05.928 | In distribution | |
| 321.05.362 | In distribution | |
| 921.04.356 | In distribution | |
| 921.04.636 | In distribution | |
| 0DAAA002 | In distribution | |
| 0DAAA001 | In distribution | |
| 321.03.332 | In distribution | |
| 321.100 | In distribution | |
| 921.206 | In distribution | |
| 50340703 | In distribution | |
| MCT710 | In distribution | |
| 321.05.366 | In distribution | |
| 921.05.368 | In distribution | |
| 921.111 | In distribution | |
| 921.05.362 | In distribution | |
| 921.03.628 | In distribution | |
| 921.04.928 | In distribution | |
| 50244552 | In distribution | |
| 3990423 | In distribution | |
| 321.04.328 | In distribution | |
| 921.104 | In distribution | |
| 321.04.356 | In distribution | |
| 921.05.728 | In distribution | |
| 321.04.028 | In distribution | |
| 3990562 | In distribution | |
| 321.05.360 | In distribution | |
| 321.05.364 | In distribution | |
| 321.035 | In distribution | |
| 321.03.232 | In distribution | |
| 321.05.128 | In distribution | |
| 921.04.728 | In distribution | |
| 921.04.628 | In distribution | |
| 921.02.350 | In distribution | |
| 321.04.232 | In distribution | |
| H399.110 | In distribution | |
| 50244503 | In distribution | |
| 921.115 | In distribution | |
| 921.106 | In distribution | |
| 321.05.032 | In distribution | |
| 0DAAA003 | In distribution | |
| E321.028 | In distribution | |
| 921.113 | In distribution | |
| 921.109 | In distribution | |
| 321.04.032 | In distribution | |
| 921.03.928 | In distribution | |
| E321.228 | In distribution | |
| 921.05.732 | In distribution | |
| S16RA001 | In distribution | |
| 9210138 | In distribution | |
| 921.03.732 | In distribution | |
| 921.128 | In distribution | |
| 321.050 | In distribution | |
| 921.110 | In distribution | |
| 321.02.028 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Iconacy i-Hip | Iconacy Orthopedic Implants, LLC | 154 |
| ZMR® | Zimmer, Inc. | 129 |
| Instrument | Howmedica Osteonics Corp | 120 |
| Restoration | Howmedica Osteonics Corp | 66 |
| U2 Hip Stem | United Orthopedic Corp. | 60 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Exactech, Inc. | 51 |
| Omnifit | Howmedica Osteonics Corp | 48 |
| Novation | Exactech, Inc. | 48 |
| Endo-Model SL Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 46 |
| Trident | Howmedica Osteonics Corp | 43 |
| Kinectiv® | Zimmer, Inc. | 41 |
| Aesculap | Aesculap AG | 38 |
Showing 12 of 131. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
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. | 6 units | 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.