U2 Total Knee System
HK Tibial trial & cemented stem trial tray
7manufacturers in China registered for this device type
43catalogue numbers in this listing
2510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| 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 |
Record
| Listed by | United Orthopedic Corp., Taiwan |
|---|---|
| FDA product code | KRO |
| Device type | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3510 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K190100 |
| Record published | 2025-07-11 |
| Record revised | 2025-08-28 (version 2) |
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 |
|---|---|---|
| 2823-2123 | In distribution | |
| 2823-2122 | In distribution | |
| 9323-8103 | In distribution | |
| 2823-2233 | In distribution | |
| 9325-8106-RA | In distribution | |
| 9325-8108 | In distribution | |
| 2823-2242 | In distribution | |
| 2823-2223 | In distribution | |
| 2823-2243 | In distribution | |
| 2823-2143 | In distribution | |
| 2823-2141 | In distribution | |
| 9325-8106 | In distribution | |
| 2823-2262 | In distribution | |
| 2823-2213 | In distribution | |
| 2823-2212 | In distribution | |
| 2823-2121 | In distribution | |
| 2823-2211 | In distribution | |
| 2823-2152 | In distribution | |
| 2823-2231 | In distribution | |
| 2823-2112 | In distribution | |
| 2823-2163 | In distribution | |
| 9325-8110 | In distribution | |
| 2823-2253 | In distribution | |
| 2823-2162 | In distribution | |
| 2823-2111 | In distribution | |
| 2823-2261 | In distribution | |
| 2823-2251 | In distribution | |
| 2823-2252 | In distribution | |
| 2823-2161 | In distribution | |
| 2823-2241 | In distribution | |
| 2823-2132 | In distribution | |
| 9325-8107 | In distribution | |
| 9325-8109 | In distribution | |
| 2823-2222 | In distribution | |
| 2823-2142 | In distribution | |
| 2823-2113 | In distribution | |
| 2823-2232 | In distribution | |
| 2823-2263 | In distribution | |
| 2823-2131 | In distribution | |
| 2823-2133 | In distribution | |
| 2823-2153 | In distribution | |
| 2823-2151 | In distribution | |
| 2823-2221 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Link Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | 324 |
| Endo-Model Modular Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 291 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 263 |
| Evolution | Microport Orthopedics Inc. | 223 |
| Legion | Smith & Nephew, Inc. | 222 |
| OSS™ Orthopedic Salvage System | Biomet Orthopedics | 211 |
| Ustar II Knee System | United Orthopedic Corp. | 185 |
| “united” Ustar II Knee System | United Orthopedic Corp. | 162 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 157 |
| Finn Knee System | Biomet Orthopedics | 138 |
| NexGen | Zimmer, Inc. | 119 |
| Triathlon | Howmedica Osteonics Corp | 106 |
Showing 12 of 109. All products under Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252303 | 2025-08-22 |
| K190100 | 2019-09-23 |
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.