Consensus® Hip System
95 catalogue numbers from 1017-1-1054, listed by Consensus Orthopedics, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.
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 | Consensus Orthopedics, Inc., United States |
|---|---|
| FDA product code | KWL |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Record published | 2015-10-24 |
| 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 32 to 61 mm |
| Distribution end date | 2021-07-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1017-1-1054 | Outer Diameter 54 mm | Withdrawn |
| 1017-0-2051 | Outer Diameter 51 mm | Withdrawn |
| 1017-0-1053 | Outer Diameter 53 mm | Withdrawn |
| 1017-0-1057 | Outer Diameter 57 mm | Withdrawn |
| 1017-1-2049 | Outer Diameter 49 mm | Withdrawn |
| 1017-0-2055 | Outer Diameter 55 mm | Withdrawn |
| 1017-0-1046 | Outer Diameter 46 mm | Withdrawn |
| 1017-1-1041 | Outer Diameter 41 mm | Withdrawn |
| 1017-0-2042 | Outer Diameter 42 mm | Withdrawn |
| 1017-1-2060 | Outer Diameter 60 mm | Withdrawn |
| 1017-0-2041 | Outer Diameter 41 mm | Withdrawn |
| 1017-1-1043 | Outer Diameter 43 mm | Withdrawn |
| 1017-1-1057 | Outer Diameter 57 mm | Withdrawn |
| 1017-1-2056 | Outer Diameter 56 mm | Withdrawn |
| 1017-0-1050 | Outer Diameter 50 mm | Withdrawn |
| 1005-0-3262 | Outer Diameter 32 mm | Withdrawn |
| 1017-1-1040 | Outer Diameter 40 mm | Withdrawn |
| 1017-0-1048 | Outer Diameter 48 mm | Withdrawn |
| 1017-0-2047 | Outer Diameter 47 mm | Withdrawn |
| 1017-1-1050 | Outer Diameter 50 mm | Withdrawn |
| 1017-1-2048 | Outer Diameter 48 mm | Withdrawn |
| 1017-1-1048 | Outer Diameter 48 mm | Withdrawn |
| 1017-1-2052 | Outer Diameter 52 mm | Withdrawn |
| 1017-0-2049 | Outer Diameter 49 mm | Withdrawn |
| 1017-1-2050 | Outer Diameter 50 mm | Withdrawn |
| 1017-0-1060 | Outer Diameter 60 mm | Withdrawn |
| 1005-0-3256 | Outer Diameter 32 mm | Withdrawn |
| 1005-0-3264 | Outer Diameter 32 mm | Withdrawn |
| 1017-1-2057 | Outer Diameter 57 mm | Withdrawn |
| 1017-0-1045 | Outer Diameter 45 mm | Withdrawn |
| 1017-0-1058 | Outer Diameter 58 mm | Withdrawn |
| 1005-0-3260 | Outer Diameter 32 mm | Withdrawn |
| 1017-1-2047 | Outer Diameter 47 mm | Withdrawn |
| 1017-1-2054 | Outer Diameter 54 mm | Withdrawn |
| 1017-0-2048 | Outer Diameter 48 mm | Withdrawn |
| 1017-0-2053 | Outer Diameter 53 mm | Withdrawn |
| 1017-0-1047 | Outer Diameter 47 mm | Withdrawn |
| 1017-1-1058 | Outer Diameter 58 mm | Withdrawn |
| 1017-1-2061 | Outer Diameter 61 mm | Withdrawn |
| 1017-0-2057 | Outer Diameter 57 mm | Withdrawn |
| 1017-1-1052 | Outer Diameter 52 mm | Withdrawn |
| 1017-1-2045 | Outer Diameter 45 mm | Withdrawn |
| 1017-1-1047 | Outer Diameter 47 mm | Withdrawn |
| 1017-1-1049 | Outer Diameter 49 mm | Withdrawn |
| 1005-0-3268 | Outer Diameter 32 mm | Withdrawn |
| 1017-1-2058 | Outer Diameter 58 mm | Withdrawn |
| 1017-0-2060 | Outer Diameter 60 mm | Withdrawn |
| 1017-1-2041 | Outer Diameter 41 mm | Withdrawn |
| 1005-0-3254 | Outer Diameter 32 mm | Withdrawn |
| 1005-0-3252 | Outer Diameter 32 mm | Withdrawn |
| 1017-0-1056 | Outer Diameter 56 mm | Withdrawn |
| 1017-1-2055 | Outer Diameter 55 mm | Withdrawn |
| 1017-1-1055 | Outer Diameter 55 mm | Withdrawn |
| 1017-0-1049 | Outer Diameter 49 mm | Withdrawn |
| 1017-1-2059 | Outer Diameter 59 mm | Withdrawn |
| 1017-0-1061 | Outer Diameter 61 mm | Withdrawn |
| 1017-0-1042 | Outer Diameter 42 mm | Withdrawn |
| 1017-1-1053 | Outer Diameter 53 mm | Withdrawn |
| 1017-0-2061 | Outer Diameter 61 mm | Withdrawn |
| 1005-0-3266 | Outer Diameter 32 mm | Withdrawn |
| 1017-1-1051 | Outer Diameter 51 mm | Withdrawn |
| 1017-0-1054 | Outer Diameter 54 mm | Withdrawn |
| 1017-1-2040 | Outer Diameter 40 mm | Withdrawn |
| 1017-1-1045 | Outer Diameter 45 mm | Withdrawn |
| 1017-1-1059 | Outer Diameter 59 mm | Withdrawn |
| 1005-0-3258 | Outer Diameter 32 mm | Withdrawn |
| 1017-0-1052 | Outer Diameter 52 mm | Withdrawn |
| 1017-0-2050 | Outer Diameter 50 mm | Withdrawn |
| 1017-0-1044 | Outer Diameter 44 mm | Withdrawn |
| 1017-0-2059 | Outer Diameter 59 mm | Withdrawn |
| 1017-1-2043 | Outer Diameter 43 mm | Withdrawn |
| 1017-0-1051 | Outer Diameter 51 mm | Withdrawn |
| 1017-0-1043 | Outer Diameter 43 mm | Withdrawn |
| 1017-0-1055 | Outer Diameter 55 mm | Withdrawn |
| 1017-1-1061 | Outer Diameter 61 mm | Withdrawn |
| 1017-0-2052 | Outer Diameter 52 mm | Withdrawn |
| 1017-0-2045 | Outer Diameter 45 mm | Withdrawn |
| 1017-1-2044 | Outer Diameter 44 mm | Withdrawn |
| 1017-0-2056 | Outer Diameter 56 mm | Withdrawn |
| 1017-1-1056 | Outer Diameter 56 mm | Withdrawn |
| 1017-0-2043 | Outer Diameter 43 mm | Withdrawn |
| 1017-0-2058 | Outer Diameter 58 mm | Withdrawn |
| 1017-1-2051 | Outer Diameter 51 mm | Withdrawn |
| 1017-0-1041 | Outer Diameter 41 mm | Withdrawn |
| 1017-0-2046 | Outer Diameter 46 mm | Withdrawn |
| 1017-1-2046 | Outer Diameter 46 mm | Withdrawn |
| 1017-1-1046 | Outer Diameter 46 mm | Withdrawn |
| 1017-1-2042 | Outer Diameter 42 mm | Withdrawn |
| 1017-0-1059 | Outer Diameter 59 mm | Withdrawn |
| 1017-1-1060 | Outer Diameter 60 mm | Withdrawn |
| 1017-1-1044 | Outer Diameter 44 mm | Withdrawn |
| 1017-1-1042 | Outer Diameter 42 mm | Withdrawn |
| 1017-1-2053 | Outer Diameter 53 mm | Withdrawn |
| 1017-0-2044 | Outer Diameter 44 mm | Withdrawn |
| 1017-0-2054 | Outer Diameter 54 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ustar II Knee System | United Orthopedic Corp. | 115 |
| Consensus Hip System | Shalby Advanced Technologies, 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 |
| DJO Surgical | Encore Medical, L.P. | 62 |
| 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
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.