Bencox Bipolar Cup System
The Bencox Bipolar Cup insert is the polyethylene bearing component within a hip arthroplasty cup. The system supplies a cobalt-chromium-molybdenum shell preassembled with a polyethylene…
The Bencox Bipolar Cup insert is the polyethylene bearing component within a hip arthroplasty cup. The system supplies a cobalt-chromium-molybdenum shell preassembled with a polyethylene liner. A separate polyethylene ring is assembled by the surgeon as part of the cup configuration.
The liner and locking ring are ultra-high-molecular-weight polyethylene. The cup is used within the Bencox bipolar hip system with its compatible femoral head and stem. The described system is a cementless metal-on-polyethylene bearing construct.
Listed Item
BENCOX Bipolar Cup 40mm-Insert
Components and Sterilization
Bencox system components are sterilized by gamma irradiation. The stem and metal head have their own titanium-alloy and cobalt-chromium-alloy constructions, distinct from the cup insert’s polyethylene. The listed insert is one bearing component rather than a complete femoral or acetabular implant assembly.
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 | Corentec Co., Ltd., South Korea |
|---|---|
| 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 | Manufacturer, Exporter |
| 510(k) | K112019 |
| Record published | 2020-04-09 |
| Record revised | 2020-09-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H2.A51.0022 | In distribution | |
| H2.A51.0040-01 | In distribution | |
| H2.A51.0046 | In distribution | |
| H2.A51.0041-01 | In distribution | |
| H2.A51.0055 | In distribution | |
| H2.A51.0044 | In distribution | |
| H2.A51.0044-01 | In distribution | |
| H2.A51.0057 | In distribution | |
| H2.A51.0041 | In distribution | |
| H2.A51.0040 | In distribution | |
| H2.A51.0051-01 | In distribution | |
| H2.A51.0039-01 | In distribution | |
| H2.A51.0045 | In distribution | |
| H2.A51.0047-01 | In distribution | |
| H2.A51.0043-01 | In distribution | |
| H2.A51.0028 | In distribution | |
| H2.A51.0056 | In distribution | |
| H2.A51.0060 | In distribution | |
| H2.A51.0053 | In distribution | |
| H2.A51.0043 | In distribution | |
| H2.A51.0055-01 | In distribution | |
| H2.A51.0049-01 | In distribution | |
| H2.A51.0051 | In distribution | |
| H2.A51.0052-01 | In distribution | |
| H2.A51.0053-01 | In distribution | |
| H2.A51.0057-01 | In distribution | |
| H2.A51.0046-01 | In distribution | |
| H2.A51.0054-01 | In distribution | |
| H2.A51.0050 | In distribution | |
| H2.A51.0052 | In distribution | |
| H2.A51.0054 | In distribution | |
| H2.A51.0060-01 | In distribution | |
| H2.A51.0050-01 | In distribution | |
| H2.A51.0039 | In distribution | |
| H2.A51.0048 | In distribution | |
| H2.A51.0048-01 | In distribution | |
| H2.A51.0038-01 | In distribution | |
| H2.A51.0042 | In distribution | |
| H2.A51.0042-01 | In distribution | |
| H2.A51.0047 | In distribution | |
| H2.A51.0045-01 | In distribution | |
| H2.A51.0056-01 | In distribution | |
| H2.A51.0049 | 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 |
|---|---|
| K112019 | 2011-10-12 |
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.