DJO Surgical
HIP, Stem, CLP, Lateral Offset, SIZE#10, Implant, Polished Neck
10manufacturers in China registered for this device type
62catalogue 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 | Encore Medical, L.P., United States |
|---|---|
| FDA product code | KWL |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K973614 |
| Record published | 2017-08-07 |
| Record revised | 2020-12-15 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 411-00-246 | In distribution | |
| 411-00-151 | In distribution | |
| 426-11-060 | In distribution | |
| 411-00-156 | In distribution | |
| 426-02-020 | In distribution | |
| 426-11-010 | In distribution | |
| 411-00-154 | In distribution | |
| 426-11-040 | In distribution | |
| 411-00-143 | In distribution | |
| 411-00-244 | In distribution | |
| 411-00-258 | In distribution | |
| 411-00-150 | In distribution | |
| 411-00-260 | In distribution | |
| 426-12-050 | In distribution | |
| 411-00-147 | In distribution | |
| 411-00-140 | In distribution | |
| 426-11-020 | In distribution | |
| 411-00-160 | In distribution | |
| 426-02-070 | In distribution | |
| 426-02-060 | In distribution | |
| 426-11-070 | In distribution | |
| 426-12-020 | In distribution | |
| 411-00-256 | In distribution | |
| 426-11-050 | In distribution | |
| 426-02-080 | In distribution | |
| 411-00-252 | In distribution | |
| 411-00-000 | In distribution | |
| 411-00-035 | In distribution | |
| 426-11-030 | In distribution | |
| 426-02-040 | In distribution | |
| 426-11-090 | In distribution | |
| 411-00-242 | In distribution | |
| 411-00-148 | In distribution | |
| 411-00-144 | In distribution | |
| 411-00-149 | In distribution | |
| 426-11-080 | In distribution | |
| 411-00-153 | In distribution | |
| 411-00-240 | In distribution | |
| 426-11-100 | In distribution | |
| 411-00-158 | In distribution | |
| 426-02-110 | In distribution | |
| 411-00-164 | In distribution | |
| 426-02-120 | In distribution | |
| 411-00-105 | In distribution | |
| 426-02-090 | In distribution | |
| 426-02-030 | In distribution | |
| 411-00-254 | In distribution | |
| 426-02-100 | In distribution | |
| 426-11-110 | In distribution | |
| 411-00-350 | In distribution | |
| 411-00-162 | In distribution | |
| 411-00-152 | In distribution | |
| 411-00-145 | In distribution | |
| 411-00-248 | In distribution | |
| 411-00-141 | In distribution | |
| 411-00-250 | In distribution | |
| 426-11-120 | In distribution | |
| 411-00-700 | In distribution | |
| 426-02-010 | In distribution | |
| 411-00-146 | In distribution | |
| 411-00-142 | In distribution | |
| 426-02-050 | 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 |
| Restoration | Howmedica Osteonics Corp | 56 |
| Optimom Modular Heads | Corin Limited | 49 |
| Corin Unipolar Modular Head | Corin Limited | 36 |
| Perfecta | Microport Orthopedics Inc. | 35 |
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 |
|---|---|---|---|---|---|---|
| Encore Medical, L.P. | 510(k) number | 2023-08-04 | Class II | Nonconforming Material/Component | Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery | 0 |
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.