Consensus® Hip System
Acetabular Cup, 20° Hood, All Poly
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 | Consensus Orthopedics, Inc., United States |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| 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 36 mm |
| Distribution end date | 2021-07-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0016-0-0001 | In distribution | |
| 1705-0-3268 | Outer Diameter 32 mm | Withdrawn |
| 1705-0-2656 | Outer Diameter 26 mm | Withdrawn |
| 0007-1-2804 | Outer Diameter 28 mm | Withdrawn |
| 0016-0-1001 | Withdrawn | |
| 0007-0-2803 | Outer Diameter 28 mm | Withdrawn |
| 1705-0-2264 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-2268 | Outer Diameter 22 mm | Withdrawn |
| 1004-0-3256 | Outer Diameter 32 mm | Withdrawn |
| 0007-1-2802 | Outer Diameter 28 mm | Withdrawn |
| 1705-0-2248 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-2266 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-2864 | Outer Diameter 28 mm | Withdrawn |
| 1705-0-2252 | Outer Diameter 22 mm | Withdrawn |
| 0007-1-3203 | Outer Diameter 32 mm | Withdrawn |
| 1004-0-3260 | Outer Diameter 32 mm | Withdrawn |
| 1705-0-2662 | Outer Diameter 26 mm | Withdrawn |
| 0007-0-2802 | Outer Diameter 28 mm | Withdrawn |
| 0007-0-2801 | Outer Diameter 28 mm | Withdrawn |
| 1705-0-2846 | Outer Diameter 28 mm | Withdrawn |
| 1705-0-2250 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-3260 | Outer Diameter 32 mm | Withdrawn |
| 1705-0-2668 | Outer Diameter 26 mm | Withdrawn |
| 1705-0-3256 | Outer Diameter 32 mm | Withdrawn |
| 1705-0-2848 | Outer Diameter 28 mm | Withdrawn |
| 0007-1-3201 | Outer Diameter 32 mm | Withdrawn |
| 1705-0-3250 | Outer Diameter 32 mm | Withdrawn |
| 1705-0-1069 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-2854 | Outer Diameter 28 mm | Withdrawn |
| 1705-0-2856 | Outer Diameter 28 mm | Withdrawn |
| 0007-0-2804 | Outer Diameter 28 mm | Withdrawn |
| 1705-0-2850 | Outer Diameter 28 mm | Withdrawn |
| 0007-1-2801 | Outer Diameter 28 mm | Withdrawn |
| 1705-0-3262 | Outer Diameter 32 mm | Withdrawn |
| 1705-0-2256 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-2868 | Outer Diameter 28 mm | Withdrawn |
| 1705-0-3266 | Outer Diameter 32 mm | Withdrawn |
| 1705-0-1057 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-2654 | Outer Diameter 26 mm | Withdrawn |
| 1705-0-1048 | Outer Diameter 22 mm | Withdrawn |
| 1004-0-3252 | Outer Diameter 32 mm | Withdrawn |
| 0007-1-2201 | Outer Diameter 22 mm | Withdrawn |
| 1004-0-3268 | Outer Diameter 32 mm | Withdrawn |
| 1705-0-2646 | Outer Diameter 26 mm | Withdrawn |
| 1705-0-2260 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-3252 | Outer Diameter 32 mm | Withdrawn |
| 1705-0-2258 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-2660 | Outer Diameter 26 mm | Withdrawn |
| 0007-1-3204 | Outer Diameter 32 mm | Withdrawn |
| 1705-0-2860 | Outer Diameter 28 mm | Withdrawn |
| 1705-0-2862 | Outer Diameter 28 mm | Withdrawn |
| 1705-0-2262 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-2246 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-2852 | Outer Diameter 28 mm | Withdrawn |
| 1705-0-3258 | Outer Diameter 32 mm | Withdrawn |
| 1705-0-1063 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-1054 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-3254 | Outer Diameter 32 mm | Withdrawn |
| 0007-1-3202 | Outer Diameter 32 mm | Withdrawn |
| 1705-0-2664 | Outer Diameter 26 mm | Withdrawn |
| 1004-0-3264 | Outer Diameter 32 mm | Withdrawn |
| 1004-0-3254 | Outer Diameter 32 mm | Withdrawn |
| 1705-0-2244 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-2648 | Outer Diameter 26 mm | Withdrawn |
| 1705-0-3264 | Outer Diameter 32 mm | Withdrawn |
| 1004-0-3258 | Outer Diameter 32 mm | Withdrawn |
| 1705-0-2666 | Outer Diameter 26 mm | Withdrawn |
| 1705-0-2866 | Outer Diameter 28 mm | Withdrawn |
| 0007-1-2204 | Outer Diameter 22 mm | Withdrawn |
| 1004-0-3668 | Outer Diameter 36 mm | Withdrawn |
| 0007-1-2203 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-2254 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-2658 | Outer Diameter 26 mm | Withdrawn |
| 1705-0-2650 | Outer Diameter 26 mm | Withdrawn |
| 1705-0-2242 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-1060 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-1066 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-2652 | Outer Diameter 26 mm | Withdrawn |
| 0007-1-2803 | Outer Diameter 28 mm | Withdrawn |
| 1004-0-3266 | Outer Diameter 32 mm | Withdrawn |
| 1004-0-3262 | Outer Diameter 32 mm | Withdrawn |
| 0007-1-2202 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-1051 | Outer Diameter 22 mm | Withdrawn |
| 1705-0-2858 | Outer Diameter 28 mm | Withdrawn |
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.