Consensus® Hip System
Femoral Stem, Collared, Tapered, Cemented
4manufacturers in China registered for this device type
57catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Consensus Orthopedics, Inc., United States |
|---|---|
| FDA product code | JDL |
| Device type | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) |
| Device class | Class 3 |
| Regulation | 21 CFR 888.3320 |
| 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 10 to 68 mm |
| Distribution end date | 2021-07-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0009-0-0010 | Outer Diameter 10 mm | Withdrawn |
| 1012-0-0015 | Outer Diameter 15 mm | Withdrawn |
| 1009-0-0015 | Outer Diameter 15 mm | Withdrawn |
| 1703-0-0050 | Outer Diameter 50 mm | Withdrawn |
| 1704-0-0068 | Outer Diameter 68 mm | Withdrawn |
| 1012-0-0013 | Outer Diameter 13 mm | Withdrawn |
| 1703-0-0044 | Outer Diameter 44 mm | Withdrawn |
| 1704-0-0046 | Outer Diameter 46 mm | Withdrawn |
| 0009-0-0019 | Outer Diameter 19 mm | Withdrawn |
| 0009-0-0013 | Outer Diameter 13 mm | Withdrawn |
| 0009-0-0020 | Outer Diameter 20 mm | Withdrawn |
| 1009-0-0010 | Outer Diameter 10 mm | Withdrawn |
| 1703-0-0054 | Outer Diameter 54 mm | Withdrawn |
| 1704-0-0044 | Outer Diameter 44 mm | Withdrawn |
| 1704-0-0050 | Outer Diameter 50 mm | Withdrawn |
| 1704-0-0042 | Outer Diameter 42 mm | Withdrawn |
| 0009-0-0012 | Outer Diameter 12 mm | Withdrawn |
| 1704-0-0058 | Outer Diameter 58 mm | Withdrawn |
| 0009-0-0014 | Outer Diameter 14 mm | Withdrawn |
| 1009-0-0011 | Outer Diameter 11 mm | Withdrawn |
| 1704-0-0060 | Outer Diameter 60 mm | Withdrawn |
| 1704-0-0054 | Outer Diameter 54 mm | Withdrawn |
| 1703-0-0042 | Outer Diameter 42 mm | Withdrawn |
| 1012-0-0016 | Outer Diameter 16 mm | Withdrawn |
| 1012-0-0012 | Outer Diameter 12 mm | Withdrawn |
| 1704-0-0056 | Outer Diameter 56 mm | Withdrawn |
| 1703-0-0048 | Outer Diameter 48 mm | Withdrawn |
| 1704-0-0064 | Outer Diameter 64 mm | Withdrawn |
| 1703-0-0056 | Outer Diameter 56 mm | Withdrawn |
| 1703-0-0058 | Outer Diameter 58 mm | Withdrawn |
| 0009-0-0023 | Outer Diameter 23 mm | Withdrawn |
| 1703-0-0046 | Outer Diameter 46 mm | Withdrawn |
| 1012-0-0014 | Outer Diameter 14 mm | Withdrawn |
| 0009-0-0017 | Outer Diameter 17 mm | Withdrawn |
| 0009-0-0011 | Outer Diameter 11 mm | Withdrawn |
| 1703-0-0068 | Outer Diameter 68 mm | Withdrawn |
| 0009-0-0015 | Outer Diameter 15 mm | Withdrawn |
| 1703-0-0066 | Outer Diameter 66 mm | Withdrawn |
| 1009-0-0012 | Outer Diameter 12 mm | Withdrawn |
| 1009-0-0013 | Outer Diameter 13 mm | Withdrawn |
| 1703-0-0052 | Outer Diameter 52 mm | Withdrawn |
| 1009-0-0014 | Outer Diameter 14 mm | Withdrawn |
| 1704-0-0066 | Outer Diameter 66 mm | Withdrawn |
| 0009-0-0022 | Outer Diameter 22 mm | Withdrawn |
| 1703-0-0062 | Outer Diameter 62 mm | Withdrawn |
| 1012-0-0010 | Outer Diameter 10 mm | Withdrawn |
| 1704-0-0052 | Outer Diameter 52 mm | Withdrawn |
| 0009-0-0016 | Outer Diameter 16 mm | Withdrawn |
| 0009-0-0024 | Outer Diameter 24 mm | Withdrawn |
| 1704-0-0048 | Outer Diameter 48 mm | Withdrawn |
| 1703-0-0060 | Outer Diameter 60 mm | Withdrawn |
| 1704-0-0062 | Outer Diameter 62 mm | Withdrawn |
| 0009-0-0018 | Outer Diameter 18 mm | Withdrawn |
| 1009-0-0016 | Outer Diameter 16 mm | Withdrawn |
| 1012-0-0011 | Outer Diameter 11 mm | Withdrawn |
| 0009-0-0021 | Outer Diameter 21 mm | Withdrawn |
| 1703-0-0064 | Outer Diameter 64 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 57 |
| Omnifit | Howmedica Osteonics Corp | 29 |
| Conserve® | Microport Orthopedics Inc. | 20 |
| Fitmore® Hip Stem | Zimmer, Inc. | 19 |
| Dynasty | Microport Orthopedics Inc. | 12 |
| Healey HIP System | Biomet Orthopedics | 12 |
| Transcend® | Microport Orthopedics Inc. | 6 |
| CLS® Brevius® Kinectiv® | Zimmer, Inc. | 6 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 6 |
| Duracon | Howmedica Osteonics Corp | 5 |
| Kinectiv® | Zimmer, Inc. | 3 |
| CLS® Brevius™ Stem | Zimmer, Inc. | 2 |
Showing 12 of 20. All products under Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
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.