Consensus® Hip System
Bipolar Assembly
14manufacturers in China registered for this device type
177catalogue numbers in this listing
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 | Consensus Orthopedics, Inc., United States |
|---|---|
| FDA product code | KWY |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3390 |
| Record published | 2015-09-24 |
| Record revised | 2021-07-29 (version 4) |
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 |
| Sizes | Outer diameter 22 to 62 mm |
| Distribution end date | 2021-07-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1020-0-2238 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1844 | Outer Diameter 28 mm | Withdrawn |
| 1018-0-4244 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-3859 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-1245 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-4255 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-3249 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1853 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-2855 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3844 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-1850 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3253 | Outer Diameter 22 mm | Withdrawn |
| 1015-0-4547 | Outer Diameter 28 mm | Withdrawn |
| 1014-0-0049 | Outer Diameter 49 mm | Withdrawn |
| 1020-0-1842 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-2847 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-2856 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3239 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-3853 | Outer Diameter 28 mm | Withdrawn |
| 1014-0-0062 | Outer Diameter 62 mm | Withdrawn |
| 1015-0-5153 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-2254 | Outer Diameter 22 mm | Withdrawn |
| 1018-0-5153 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-3858 | Outer Diameter 28 mm | Withdrawn |
| 1015-0-6062 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-2246 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-3847 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3242 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1242 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-4246 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2854 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-1253 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1247 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2250 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1254 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1246 | Outer Diameter 22 mm | Withdrawn |
| 1018-0-4850 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1846 | Outer Diameter 28 mm | Withdrawn |
| 1015-0-5456 | Outer Diameter 28 mm | Withdrawn |
| 1018-0-3841 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1847 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-2862 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3862 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-1858 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-4253 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2845 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-1845 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-2858 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-4254 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-3252 | Outer Diameter 22 mm | Withdrawn |
| 1014-0-0043 | Outer Diameter 43 mm | Withdrawn |
| 1020-0-2853 | Outer Diameter 28 mm | Withdrawn |
| 1014-0-0041 | Outer Diameter 41 mm | Withdrawn |
| 1020-0-4238 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2240 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-3849 | Outer Diameter 28 mm | Withdrawn |
| 1018-0-5456 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-3843 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-4245 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1854 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-1252 | Outer Diameter 22 mm | Withdrawn |
| 1014-0-0058 | Outer Diameter 58 mm | Withdrawn |
| 1020-0-2857 | Outer Diameter 28 mm | Withdrawn |
| 1014-0-0050 | Outer Diameter 50 mm | Withdrawn |
| 1020-0-4244 | Outer Diameter 22 mm | Withdrawn |
| 1014-0-0044 | Outer Diameter 44 mm | Withdrawn |
| 1020-0-2249 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2248 | Outer Diameter 22 mm | Withdrawn |
| 1014-0-0048 | Outer Diameter 48 mm | Withdrawn |
| 1014-0-0052 | Outer Diameter 52 mm | Withdrawn |
| 1020-0-2256 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-4250 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2251 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1856 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-2241 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1862 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3243 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-3245 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2842 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3855 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3860 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-1249 | Outer Diameter 22 mm | Withdrawn |
| 1015-0-5759 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3854 | Outer Diameter 28 mm | Withdrawn |
| 1014-0-0060 | Outer Diameter 60 mm | Withdrawn |
| 1020-0-3241 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1852 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-2851 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3248 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2239 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2247 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1241 | Outer Diameter 22 mm | Withdrawn |
| 1014-0-0040 | Outer Diameter 40 mm | Withdrawn |
| 1014-0-0046 | Outer Diameter 46 mm | Withdrawn |
| 1020-0-4243 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2252 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2860 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-1248 | Outer Diameter 22 mm | Withdrawn |
| 1014-0-0039 | Outer Diameter 39 mm | Withdrawn |
| 1015-0-4244 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-4249 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1250 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1243 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1861 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-1848 | Outer Diameter 28 mm | Withdrawn |
| 1014-0-0042 | Outer Diameter 42 mm | Withdrawn |
| 1020-0-2852 | Outer Diameter 28 mm | Withdrawn |
| 1014-0-0059 | Outer Diameter 59 mm | Withdrawn |
| 1020-0-3247 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-3842 | Outer Diameter 28 mm | Withdrawn |
| 1014-0-0051 | Outer Diameter 51 mm | Withdrawn |
| 1020-0-4248 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-4240 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1859 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-2859 | Outer Diameter 28 mm | Withdrawn |
| 1014-0-0047 | Outer Diameter 47 mm | Withdrawn |
| 1020-0-4247 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1855 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-2243 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-4241 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-3254 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-3856 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3250 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-3848 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-2846 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3246 | Outer Diameter 22 mm | Withdrawn |
| 1014-0-0053 | Outer Diameter 53 mm | Withdrawn |
| 1020-0-2861 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-2848 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3846 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3240 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1244 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2242 | Outer Diameter 22 mm | Withdrawn |
| 1014-0-0055 | Outer Diameter 55 mm | Withdrawn |
| 1020-0-4252 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1851 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3851 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-4256 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-3861 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-1238 | Outer Diameter 22 mm | Withdrawn |
| 1015-0-4850 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3244 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2253 | Outer Diameter 22 mm | Withdrawn |
| 1014-0-0038 | Outer Diameter 38 mm | Withdrawn |
| 1014-0-0057 | Outer Diameter 57 mm | Withdrawn |
| 1020-0-1849 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3852 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-2245 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-3850 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-2849 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-4239 | Outer Diameter 22 mm | Withdrawn |
| 1014-0-0045 | Outer Diameter 45 mm | Withdrawn |
| 1020-0-4242 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2844 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-1240 | Outer Diameter 22 mm | Withdrawn |
| 1014-0-0054 | Outer Diameter 54 mm | Withdrawn |
| 1020-0-4251 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2850 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3857 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-2843 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3255 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2255 | Outer Diameter 22 mm | Withdrawn |
| 1018-0-4547 | Outer Diameter 22 mm | Withdrawn |
| 1014-0-0056 | Outer Diameter 56 mm | Withdrawn |
| 1020-0-3251 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-3238 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1239 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1857 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3256 | Outer Diameter 22 mm | Withdrawn |
| 1014-0-0061 | Outer Diameter 61 mm | Withdrawn |
| 1020-0-1843 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-3845 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-1256 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1255 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-1860 | Outer Diameter 28 mm | Withdrawn |
| 1020-0-1251 | Outer Diameter 22 mm | Withdrawn |
| 1020-0-2244 | Outer Diameter 22 mm | Withdrawn |
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 | 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 |
| Corin BiPolar-i | Corin Limited | 54 |
Showing 12 of 352. All products under Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
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.