Tibial Baseplate, #1
Catalogue number 2215-1410, listed by United Orthopedic Corp., Taiwan, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
1catalogue number
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 | United Orthopedic Corp., Taiwan |
|---|---|
| FDA product code | KWL |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K190100 |
| Record published | 2019-10-08 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2215-1410 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ustar II Knee System | United Orthopedic Corp. | 115 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 95 |
| Consensus® Hip System | Consensus Orthopedics, 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 |
Showing 12 of 167. All products under Prosthesis, Hip, Hemi-, Femoral, Metal
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| United Orthopedic Corp. | 510(k) number | 2026-05-20 | Class II | Process design | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. | 2 | |
| United Orthopedic Corp. | 510(k) number | 2024-01-03 | Class II | Nonconforming Material/Component | Their is a potential that the implant curved stem may be oriented incorrectly. | 598 units | |
| United Orthopedic Corp. | 510(k) number | 2024-01-03 | Class II | Nonconforming Material/Component | Their is a potential that the implant curved stem may be oriented incorrectly. | 479 units | |
| United Orthopedic Corp. | 510(k) number | 2024-01-03 | Class II | Nonconforming Material/Component | Their is a potential that the implant curved stem may be oriented incorrectly. | ||
| UOC USA Inc. | 510(k) number | 2021-08-27 | Class II | Device Design | Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing. | 3 devices | 2023-01-20 |
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.