U-Motion II™
U-Motion II Acetabular liner trial, 20°, ID36mm, OD54mm
13manufacturers in China registered for this device type
58catalogue 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 | United Orthopedic Corp., Taiwan |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K122185 |
| Record published | 2017-05-19 |
| Record revised | 2020-12-21 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1406-6654 | 20°, ID36mm, OD54mm, | In distribution |
| 1306-2054 | 54mm | In distribution |
| 1406-6656 | 20°, ID36mm, OD56mm, | In distribution |
| 1406-4652 | ID36mm, OD52mm | In distribution |
| 1406-4060 | ID40mm, OD60mm | In distribution |
| 1406-6846 | 20°, ID28mm, OD46mm | In distribution |
| 1406-6668 | 20°, ID36mm, OD68mm, | In distribution |
| 1406-6660 | 20°, ID36mm, OD60mm, | In distribution |
| 1306-2066 | 66mm | In distribution |
| 1406-4662 | ID36mm, OD62mm | In distribution |
| 1406-4666 | ID36mm, OD66mm | In distribution |
| 1406-6248 | 20°, ID32mm, OD48mm, | In distribution |
| 1406-4062 | ID40mm, OD62mm | In distribution |
| 1406-4668 | ID36mm, OD68mm | In distribution |
| 1306-2052 | 52mm | In distribution |
| 1406-4660 | ID36mm, OD60mm | In distribution |
| 1406-6651 | 20°, ID36mm, OD50mm | In distribution |
| 1406-4654 | ID36mm, OD54mm | In distribution |
| 1306-2068 | 68mm | In distribution |
| 1406-6058 | 20°, ID40mm, OD58mm, | In distribution |
| 1406-6664 | 20°, ID36mm, OD64mm, | In distribution |
| 1406-6060 | 20°, ID40mm, OD60mm, | In distribution |
| 1406-6056 | 20°, ID40mm, OD56mm, | In distribution |
| 1306-2044 | 44mm | In distribution |
| 1406-6844 | 20°, ID28mm, OD44mm, | In distribution |
| 1406-4248 | ID32mm, OD48mm | In distribution |
| 1406-4064 | ID40mm, OD64mm | In distribution |
| 1406-6666 | 20°, ID36mm, OD66mm, | In distribution |
| 1406-4651 | 0°, ID36mm, OD50mm | In distribution |
| 1406-6068 | 20°, ID40mm, OD68mm, | In distribution |
| 1306-2060 | 60mm | In distribution |
| 1306-2064 | 62mm | In distribution |
| 1406-6250 | 20°, ID32mm, OD50mm, | In distribution |
| 1406-6670 | 20°, ID36mm, OD70mm, | In distribution |
| 1406-4656 | ID36mm, OD56mm | In distribution |
| 1406-6658 | 20°, ID36mm, OD58mm, | In distribution |
| 1406-4247 | 0°, ID32mm, OD46mm | In distribution |
| 1406-6247 | 20°, ID32mm, OD46mm | In distribution |
| 1306-2046 | 46mm | In distribution |
| 1406-6064 | 20°, ID40mm, OD64mm, | In distribution |
| 1406-4070 | ID40mm, OD70mm | In distribution |
| 1406-6066 | 20°, ID40mm, OD66mm, | In distribution |
| 1306-2062 | 62mm | In distribution |
| 1406-4066 | ID40mm, OD66mm | In distribution |
| 1406-6070 | 20°, ID40mm, OD70mm, | In distribution |
| 1406-6652 | 20°, ID36mm, OD52mm, | In distribution |
| 1406-4658 | ID36mm, OD58mm | In distribution |
| 1406-6062 | 20°, ID40mm, OD62mm, | In distribution |
| 1406-4068 | ID40mm, OD68mm | In distribution |
| 1306-2050 | 50mm | In distribution |
| 1406-4670 | ID36mm, OD70mm | In distribution |
| 1406-4846 | ID28mm, OD46mm | In distribution |
| 1406-4844 | ID28mm, OD44mm | In distribution |
| 1406-4664 | ID36mm, OD64mm | In distribution |
| 1306-2048 | 48mm | In distribution |
| 1306-2056 | 56mm | In distribution |
| 1306-2070 | 70mm | In distribution |
| 1306-2058 | 58mm | 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 |
|---|---|
| K191056 | 2020-01-03 |
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.