Bipolar II™
U2 Bipolar trial, Ø39mm, ID 22mm
14manufacturers in China registered for this device type
23catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), 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 |
| 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 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| 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 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Record
| Listed by | United Orthopedic Corp., Taiwan |
|---|---|
| FDA product code | KWY |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3390 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K152439 |
| Record published | 2017-05-19 |
| Record revised | 2022-09-16 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1503-4339 | Ø39mm, ID 22mm | In distribution |
| 1503-4156 | φ56mm, ID 28mm | In distribution |
| 1503-4340 | Ø40mm, ID 22mm | In distribution |
| 1503-4144 | φ44mm, ID 28mm | In distribution |
| 1503-4149 | φ49mm, ID 28mm | In distribution |
| 1503-4147 | φ47mm, ID 28mm | In distribution |
| 1503-4148 | φ48mm, ID 28mm | In distribution |
| 1503-4154 | φ54mm, ID 28mm | In distribution |
| 1503-4145 | φ45mm, ID 28mm | In distribution |
| 1503-4342 | Ø42mm, ID 22mm | In distribution |
| 1503-4041 | φ41mm, ID 26mm | In distribution |
| 1503-4155 | φ55mm, ID 28mm | In distribution |
| 1503-4152 | φ52mm, ID 28mm | In distribution |
| 1503-4338 | Ø38mm, ID 22mm | In distribution |
| 1503-4042 | φ42mm, ID 26mm | In distribution |
| 1503-4150 | φ50mm, ID 28mm | In distribution |
| 1503-4146 | φ46mm, ID 28mm | In distribution |
| 9204-8041-RC | In distribution | |
| 1503-4341 | Ø41mm, ID 22mm | In distribution |
| 1503-4151 | φ51mm, ID 28mm | In distribution |
| 9204-8041 | In distribution | |
| 1503-4143 | φ43mm, ID 28mm | In distribution |
| 1503-4153 | φ53mm, ID 28mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 196 |
| Corin Bipolar Prosthesis | Corin Limited | 182 |
| Consensus® Hip System | Consensus Orthopedics, Inc. | 177 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 177 |
| Instrument | Howmedica Osteonics Corp | 130 |
| Bencox Hip System | Corentec Co., Ltd. | 126 |
| United Hip System, U2 Bipolar Implant | United Orthopedic Corp. | 123 |
| MultiPolar® | Zimmer, Inc. | 100 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Zimmer, Inc. | 96 |
| Fitmore® Hip Stem | Zimmer, Inc. | 75 |
| Arcos® Modular Revision System | Biomet Orthopedics | 67 |
| Acumatch L-Series | Exactech, Inc. | 67 |
Showing 12 of 352. All products under Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152439 | 2016-04-07 |
| K101670 | 2010-10-08 |
| K050269 | 2005-08-29 |
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.