Libertas
12/14 Taper HNSS 28/+3.5 Modular Femoral Head
13manufacturers in China registered for this device type
71catalogue numbers in this listing
1510(k) clearance
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 | Maxx 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 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K180973 |
| Record published | 2025-07-23 |
| Record revised | 2024-02-19 (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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MO-MSBC-62/52 | In distribution | |
| MO-HDAM-28/35+ | In distribution | |
| MO-STCM-00/02 | In distribution | |
| MO-HDAM-28/35- | In distribution | |
| MO-MLHE-MD/32 | In distribution | |
| MO-HDAA-28/70+ | In distribution | |
| MO-HDAA-36/00 | In distribution | |
| MO-MSFC-50/MD | In distribution | |
| MO-MSBC-60/52 | In distribution | |
| MO-MSFC-64/MJ | In distribution | |
| MO-MLHE-MJ/40 | In distribution | |
| MO-HDAA-36/70+ | In distribution | |
| MO-MLHE-MJ/32 | In distribution | |
| MO-HDAI-32/40+ | In distribution | |
| MO-HDAM-40/40- | In distribution | |
| MO-HDAI-36/40+ | In distribution | |
| MO-MSBC-48/40 | In distribution | |
| MO-SWCC-65/35 | In distribution | |
| MO-MSBC-68/52 | In distribution | |
| MO-HDAM-32/40- | In distribution | |
| MO-STDM-00/03 | In distribution | |
| MO-MSFC-58/MH | In distribution | |
| MO-HDAA-40/40- | In distribution | |
| MO-HDAM-36/70+ | In distribution | |
| MO-HDAI-28/35+ | In distribution | |
| MO-HDAM-32/70+ | In distribution | |
| MO-MSBC-46/40 | In distribution | |
| MO-HDAI-36/40- | In distribution | |
| MO-MSBC-52/44 | In distribution | |
| MO-STDM-00/02 | In distribution | |
| MO-HDAI-36/80+ | In distribution | |
| MO-MSAC-44/37 | In distribution | |
| MO-MLHE-MF/36 | In distribution | |
| MO-HDAM-40/70+ | In distribution | |
| MO-HDAA-40/70+ | In distribution | |
| MO-HDAA-40/40+ | In distribution | |
| MO-HDAM-36/40+ | In distribution | |
| MO-SWCC-65/40 | In distribution | |
| MO-HDAM-36/40- | In distribution | |
| MO-HDAM-36/00 | In distribution | |
| MO-SWCC-65/15 | In distribution | |
| MO-MSBC-56/48 | In distribution | |
| MO-MSBC-54/44 | In distribution | |
| MO-MLHE-MF/28 | In distribution | |
| MO-SWCC-65/45 | In distribution | |
| MO-HDAA-22/35+ | In distribution | |
| MO-HDAM-22/00 | In distribution | |
| MO-HDAI-32/00 | In distribution | |
| MO-HDAM-32/40+ | In distribution | |
| MO-HDAM-40/40+ | In distribution | |
| MO-MLHE-MJ/36 | In distribution | |
| MO-HDAI-40/00 | In distribution | |
| MO-STCM-00/00 | In distribution | |
| MO-HDAA-32/40+ | In distribution | |
| MO-MSBC-70/52 | In distribution | |
| MO-MLHE-MH/32 | In distribution | |
| MO-MSBC-64/52 | In distribution | |
| MO-MSBC-58/48 | In distribution | |
| MO-HDAM-40/00 | In distribution | |
| MO-HDAM-22/35+ | In distribution | |
| MO-MSFC-68/MK | In distribution | |
| MO-AOAC-10/35 | In distribution | |
| MO-HDAM-28/00 | In distribution | |
| MO-MLHE-MK/32 | In distribution | |
| MO-MSFC-60/MJ | In distribution | |
| MO-MSFC-56/MH | In distribution | |
| MO-MSBC-50/44 | In distribution | |
| MO-HDAM-28/70+ | In distribution | |
| MO-MSFC-48/MD | In distribution | |
| MO-MSBC-66/52 | In distribution | |
| MO-HDAM-32/00 | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180973 | 2018-09-28 |
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.