Ustar II Knee System
USTAR II Cement stem trial adaptor, non coated, Ø15mm~Ø19mm
10manufacturers in China registered for this device type
115catalogue numbers in this listing
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 | 2019-12-26 |
| Record revised | 2022-09-16 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2715-6209 | In distribution | |
| 2315-2243 | In distribution | |
| 9415-9300 | In distribution | |
| 9315-8307 | In distribution | |
| 9415-9115 | In distribution | |
| 2815-2153 | In distribution | |
| 2915-2150 | In distribution | |
| 2915-2050 | In distribution | |
| 9415-9017 | In distribution | |
| 2815-2253 | In distribution | |
| 2815-2131 | In distribution | |
| 2215-2430 | In distribution | |
| 2315-2214 | In distribution | |
| 2215-2460 | In distribution | |
| 2715-6314 | In distribution | |
| 9315-9109 | In distribution | |
| 9415-9009 | In distribution | |
| 2815-2261 | In distribution | |
| 9315-8309 | In distribution | |
| 9315-8304 | In distribution | |
| 9315-9217 | In distribution | |
| 2815-2132 | In distribution | |
| 2315-2247 | In distribution | |
| 2715-6109 | In distribution | |
| 2215-2420 | In distribution | |
| 9315-8312 | In distribution | |
| 2815-2112 | In distribution | |
| 2315-2244 | In distribution | |
| 9315-8315 | In distribution | |
| 2315-2217 | In distribution | |
| 2915-2025 | In distribution | |
| 2815-2242 | In distribution | |
| 2815-2232 | In distribution | |
| 2815-2113 | In distribution | |
| 2815-2111 | In distribution | |
| 9315-8306 | In distribution | |
| 9315-9113 | In distribution | |
| 2815-2211 | In distribution | |
| 9415-9301 | In distribution | |
| 2915-2070 | In distribution | |
| 2315-2216 | In distribution | |
| 2315-2212 | In distribution | |
| 2915-2040 | In distribution | |
| 2815-2233 | In distribution | |
| 2815-2163 | In distribution | |
| 2315-2213 | In distribution | |
| 9901-8104 | In distribution | |
| 2815-2223 | In distribution | |
| 2815-2133 | In distribution | |
| 2315-2215 | In distribution | |
| 2815-2213 | In distribution | |
| 9415-9111 | In distribution | |
| 2815-2252 | In distribution | |
| 9315-8313 | In distribution | |
| 9315-9111 | In distribution | |
| 9415-9113 | In distribution | |
| 9315-8314 | In distribution | |
| 2815-2141 | In distribution | |
| 2815-2221 | In distribution | |
| 2915-2060 | In distribution | |
| 2315-2211 | In distribution | |
| 2715-6409 | In distribution | |
| 9415-9011 | In distribution | |
| 9315-8310 | In distribution | |
| 2815-2251 | In distribution | |
| 2815-2161 | In distribution | |
| 2215-2410 | In distribution | |
| 2515-4009 | In distribution | |
| 2815-2143 | In distribution | |
| 2815-2162 | In distribution | |
| 9115-8300 | In distribution | |
| 9415-9013 | In distribution | |
| 2815-2123 | In distribution | |
| 2815-2121 | In distribution | |
| 2815-2222 | In distribution | |
| 9315-8302 | In distribution | |
| 9315-8303 | In distribution | |
| 9315-9215 | In distribution | |
| 2815-2212 | In distribution | |
| 9315-8305 | In distribution | |
| 9415-6001 | In distribution | |
| 2715-6309 | In distribution | |
| 2815-2231 | In distribution | |
| 9315-8311 | In distribution | |
| 9315-8301 | In distribution | |
| 2315-2241 | In distribution | |
| 2815-2262 | In distribution | |
| 2515-2009 | In distribution | |
| 9415-6003 | In distribution | |
| 2315-2242 | In distribution | |
| 9315-8308 | In distribution | |
| 9901-8101 | In distribution | |
| 2915-2110 | In distribution | |
| 2815-2241 | In distribution | |
| 2815-2243 | In distribution | |
| 2915-2030 | In distribution | |
| 9315-9117 | In distribution | |
| 9415-9117 | In distribution | |
| 9415-9015 | In distribution | |
| 2215-2440 | In distribution | |
| 9415-6000 | In distribution | |
| 9315-9211 | In distribution | |
| 9415-6002 | In distribution | |
| 9315-9209 | In distribution | |
| 9415-9109 | In distribution | |
| 2815-2122 | In distribution | |
| 9315-9213 | In distribution | |
| 2315-2246 | In distribution | |
| 2315-2245 | In distribution | |
| 2215-2450 | In distribution | |
| 2515-2015 | In distribution | |
| 2815-2263 | In distribution | |
| 2515-4015 | In distribution | |
| 9315-9115 | In distribution | |
| 2815-2142 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Perfecta | Microport Orthopedics Inc. | 35 |
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.