Performa
Collarless Hip Stem for cemented applications - Size 6 (165 x 14mm) LONG (12/14 Taper)
13manufacturers in China registered for this device type
24catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| 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 |
Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Record
| Listed by | Implants Intl. Ltd., United Kingdom |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K923898 |
| Record published | 2016-07-31 |
| Record revised | 2024-04-08 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Room temperature and Dry |
| Sizes | Length 65 to 165 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Collarless Hip Stem – Size 6 (165 x 14mm) LONG | Length 165 mm | In distribution |
| Collared Hip Stem – Size 4 (149 x 12mm) | Length 149 mm | In distribution |
| Collared Hip Stem – Size 3 (146 x 11mm) | Length 146 mm | In distribution |
| Collared Hip Stem – Size 1 (139 x 9mm) | Length 139 mm | In distribution |
| Collarless Hip Stem – Size 8 (163 x 16mm) | Length 163 mm | In distribution |
| Collared Hip Stem – Size 3-1 (165 x 11mm) LONG | Length 165 mm | In distribution |
| Collared Hip Stem – Size 2 (142 x 10mm) | Length 142 mm | In distribution |
| Collared Hip Stem – Size 5 (153 x 13mm) | Length 153 mm | In distribution |
| Collarless Hip Stem – Size 4 (149 x 12mm) | Length 149 mm | In distribution |
| Collarless Hip Stem – Size 6 (156 x 14mm) | Length 156 mm | In distribution |
| Collarless Hip Stem – Size 1 (139 x 9mm) | Length 139 mm | In distribution |
| Collarless Hip Stem – Size 2 (142 x 10mm) | Length 142 mm | In distribution |
| Collared Hip Stem – Size 4 (165 x 12mm) LONG | Length 165 mm | In distribution |
| Collared Hip Stem – Size 6 (156 x 14mm) | Length 156 mm | In distribution |
| Collared Hip Stem – Size 7 (160 x 15mm) | Length 160 mm | In distribution |
| Collared Hip Stem – Size 8 (163 x 16mm) | Length 163 mm | In distribution |
| Collarless Hip Stem – Size 3 (165 x 11mm) LONG | Length 165 mm | In distribution |
| Collared Hip Stem – Size 5 (165 x 13mm) LONG | Length 165 mm | In distribution |
| Collarless Hip Stem – Size 5 (165 x 13mm) LONG | Length 165 mm | In distribution |
| Collarless Hip Stem – Size 4 (165 x 12mm) LONG | Length 65 mm | In distribution |
| Collared Hip Stem – Size 6 (165 x 14mm) LONG | Length 165 mm | In distribution |
| Collarless Hip Stem – Size 3 (146 x 11mm) | Length 146 mm | In distribution |
| Collarless Hip Stem – Size 7 (160 x 15mm) | Length 160 mm | In distribution |
| Collarless Hip Stem – Size 5 (153 x 13mm) | Length 153 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Zimmer, Inc. | 836 |
| R3 | Smith & Nephew, Inc. | 497 |
| UniSyn Hip System | Shalby Advanced Technologies, Inc. | 247 |
| UniSyn® Hip System | Consensus Orthopedics, Inc. | 247 |
| Reflection | Smith & Nephew, Inc. | 170 |
| Instrument | Howmedica Osteonics Corp | 167 |
| Echelon | Smith & Nephew, Inc. | 159 |
| B-P Total HIP System | Endotec, Inc. | 151 |
| ZCA® | Zimmer, Inc. | 149 |
| Omnifit | Howmedica Osteonics Corp | 149 |
| Ringloc HIP System | Biomet Orthopedics | 139 |
| Profemur | Microport Orthopedics Inc. | 113 |
Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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.