U2™ Knee
Patellar trial, on set, 3 pegs, E-large, φ44mm
21manufacturers in China registered for this device type
201catalogue numbers in this listing
20510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 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 |
| 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 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | United Orthopedic Corp., Taiwan |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K120507 |
| Record published | 2017-05-15 |
| Record revised | 2022-03-22 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9403-6030 | L | In distribution |
| 2703-6025 | PSA, φ18×100mm | In distribution |
| 2104-2215 | #1.5, right | In distribution |
| 2703-6132 | PSA , φ11 × 150mm | In distribution |
| 2103-6260 | PSA, #6, right, | In distribution |
| 2603-6363 | distal only, #6, 12mm, | In distribution |
| 2303-2433 | UC, #3, 13mm, | In distribution |
| 2203-4020-RB | #2 | In distribution |
| 9403-7340 | #4 | In distribution |
| 2703-6061 | PSA,Ø 10×200 mm | In distribution |
| 2103-2120 | CR, #2, left, | In distribution |
| 9403-7313 | 13mm | In distribution |
| 2703-6072 | PSA,Ø12 x240 mm | In distribution |
| 2103-2220 | CR, #2, right, | In distribution |
| 2703-6155 | PSA, ψ17 x 150mm | In distribution |
| 2703-6116 | PSA, φ19×75mm | In distribution |
| 2303-2234 | CR, plained, #3, 13mm | In distribution |
| 2303-2475 | UC, #7, 18mm, | In distribution |
| 2603-6011 | #1, 4mm | In distribution |
| 2703-6167 | PSA,Ø21 x200 mm | In distribution |
| 2603-6333 | distal only, #3, 12mm, | In distribution |
| 2303-2254 | CR, plained, #5, 15mm | In distribution |
| 2703-6176 | PSA,Ø 19×240 mm | In distribution |
| 2703-6136 | PSA , φ19 × 150mm | In distribution |
| 2703-6077 | PSA,Ø22 x240 mm | In distribution |
| 2303-2444 | UC, #4, 15mm, | In distribution |
| 2303-2424 | UC, #2, 15mm, | In distribution |
| 2803-6271 | #7, 5mm, right, | In distribution |
| 2303-2243 | CR, plained, #4, 13mm | In distribution |
| 2703-6057 | PSA, ψ22 x 150mm | In distribution |
| 2803-6261 | #6, 5mm, right, | In distribution |
| 2703-6126 | PSA, φ19×100mm | In distribution |
| 2303-2464 | UC, #6, 15mm, | In distribution |
| 2703-6111 | PSA, φ9×75mm | In distribution |
| 2603-6313 | distal only, #1, 12mm, | In distribution |
| 2204-4030 | #3 | In distribution |
| 2703-6076 | PSA,Ø 20×240 mm | In distribution |
| 2103-6140 | PSA, #4, left, | In distribution |
| 2603-6261 | RM/LL, #6, 4mm, | In distribution |
| 2104-2140 | #4, left | In distribution |
| 2203-4050-RA | #5 | In distribution |
| 2703-6073 | PSA,Ø 14×240 mm | In distribution |
| 2103-6160 | PSA, #6, left, | In distribution |
| 2703-6065 | PSA,Ø 18×200 mm | In distribution |
| 2103-4230 | PS, #3, right, | In distribution |
| 9403-7320 | #2 | In distribution |
| 2703-6147 | PSA , φ21 × 200mm | In distribution |
| 2703-6174 | PSA,Ø 15×240 mm | In distribution |
| 2203-6020 | PSA, #2 | In distribution |
| 2304-2420 | UC, #2 | In distribution |
| 2703-6075 | PSA,Ø 18×240 mm | In distribution |
| 2703-6053 | PSA, ψ14 x 150mm | In distribution |
| 2703-6023 | PSA, φ14×100mm | In distribution |
| 2703-6133 | PSA , φ13 × 150mm | In distribution |
| 2703-6047 | PSA , φ22 × 200mm | In distribution |
| 2103-4120 | PS, #2, left,, | In distribution |
| 2103-2270 | CR, #7, right, | In distribution |
| 2303-2462 | UC, #6, 11mm, | In distribution |
| 2203-4050-RB | #5 | In distribution |
| 2703-6125 | PSA, φ17×100mm | In distribution |
| 2104-2170 | #7, left | In distribution |
| 2303-2252 | CR, plained, #5, 11mm | In distribution |
| 2303-4012 | PS, #1, 11mm, | In distribution |
| 2103-4140 | PS, #4, left, | In distribution |
| 2703-6151 | PSA, ψ9 x 150mm | In distribution |
| 2303-2442 | UC, #4, 11mm, | In distribution |
| 9403-6011 | S | In distribution |
| 2203-4070-RB | #7 | In distribution |
| 2703-6068 | PSA,Ø 24×200 mm | In distribution |
| 9403-7317 | 25mm | In distribution |
| 2703-6113 | PSA, φ13×75mm | In distribution |
| 2603-6343 | distal only, #4, 12mm, | In distribution |
| 2203-4040-RB | #4 | In distribution |
| 2303-2261 | CR, plained, #6, 9mm | In distribution |
| 2104-2130 | #3, left | In distribution |
| 2703-6058 | PSA, Ø24×150mm | In distribution |
| 2603-6021 | #2, 4mm | In distribution |
| 2703-6041 | PSA , φ10 × 200mm | In distribution |
| 2104-2245 | #4.5, right | In distribution |
| 2703-6168 | PSA,Ø23 x200 mm | In distribution |
| 2103-6220 | PSA, #2, right, | In distribution |
| 2403-2040 | on set,3 pegs,large,φ35mm | In distribution |
| 2703-6177 | PSA,Ø21 x240 mm | In distribution |
| 2703-6011 | PSA, φ10×75mm | In distribution |
| 2103-2260 | CR, #6, right, | In distribution |
| 2703-6161 | PSA,Ø 9×200 mm | In distribution |
| 2303-2473 | UC, #7, 13mm, | In distribution |
| 2703-6038 | PSA , φ24 × 150mm | In distribution |
| 2303-2455 | UC, #5, 18mm, | In distribution |
| 2703-6055 | PSA, ψ18 x 150mm | In distribution |
| 2303-2413 | UC, #1, 13mm, | In distribution |
| 2104-2150 | #5, left | In distribution |
| 2703-6037 | PSA , φ22 × 150mm | In distribution |
| 2303-2214 | CR, plained, #1, 15mm | In distribution |
| 9403-7360 | #6 | In distribution |
| 2303-2241 | CR, plained, #4, 9mm | In distribution |
| 2303-2245 | CR, plained, #4, 18mm | In distribution |
| 2703-6071 | PSA,Ø 10×240 mm | In distribution |
| 2703-6051 | PSA, ψ10 x150mm | In distribution |
| 2304-2410 | UC, #1 | In distribution |
| 2703-6171 | PSA,Ø9 x240 mm | In distribution |
| 2703-6175 | PSA,Ø 17×240 mm | In distribution |
| 2703-6045 | PSA , φ18 × 200mm | In distribution |
| 2703-6078 | PSA,Ø24 x240 mm | In distribution |
| 2303-2453 | UC, #5, 13mm, | In distribution |
| 2703-6074 | PSA,Ø 16×240 mm | In distribution |
| 2303-2415 | UC, #1, 18mm, | In distribution |
| 9403-7315 | 18mm | In distribution |
| 2103-4250 | PS, #5, right, | In distribution |
| 2703-6141 | PSA , φ9 × 200mm | In distribution |
| 2104-2160 | #6, left | In distribution |
| 2703-6164 | PSA,Ø 15×200 mm | In distribution |
| 2703-6033 | PSA , φ14 × 150mm | In distribution |
| 2703-6035 | PSA , φ18 × 150mm | In distribution |
| 2203-4030-RA | #3 | In distribution |
| 2303-2225 | CR, plained, #2, 18mm | In distribution |
| 2303-2451 | UC, #5, 9mm, | In distribution |
| 2103-2240 | CR, #4, right, | In distribution |
| 2703-6156 | PSA, ψ19 x 150mm | In distribution |
| 2303-2435 | UC, #3, 18mm, | In distribution |
| 2703-6112 | PSA, φ11×75mm | In distribution |
| 2603-6364 | distal only, #6, 16mm, | In distribution |
| 2703-6063 | PSA,Ø14 x200 mm | In distribution |
| 2703-6152 | PSA, ψ11 x 150mm | In distribution |
| 2103-4160 | PS, #6, left, | In distribution |
| 2303-2274 | CR, plained, #7, 15mm | In distribution |
| 2303-2272 | CR, plained, #7, 11mm | In distribution |
| 2703-6145 | PSA , φ17 × 200mm | In distribution |
| 2204-4050 | #5 | In distribution |
| 2303-2471 | UC, #7, 9mm, | In distribution |
| 2104-2235 | #3.5, right | In distribution |
| 2103-4210 | PS, #1, right, | In distribution |
| 2703-6021 | PSA, φ10×100mm | In distribution |
| 2703-6165 | PSA,Ø17 x200 mm | In distribution |
| 2703-6138 | PSA , φ23 × 150mm | In distribution |
| 2703-6166 | PSA,Ø 19×200 mm | In distribution |
| 2703-6123 | PSA, φ13×100mm | In distribution |
| 2703-6122 | PSA, φ11×100mm | In distribution |
| 2603-6031 | #3, 4mm | In distribution |
| 2104-2260 | #5.5, right | In distribution |
| 2703-6173 | PSA,Ø 13×240 mm | In distribution |
| 2703-6163 | PSA,Ø13 x200 mm | In distribution |
| 2703-6162 | PSA,Ø11 x200 mm | In distribution |
| 2703-6043 | PSA , φ14 × 200mm | In distribution |
| 2104-2225 | #2.5, right | In distribution |
| 2303-2223 | CR, plained, #2, 13mm | In distribution |
| 2703-6146 | PSA , φ19 × 200mm | In distribution |
| 2703-6121 | PSA, φ9×100mm | In distribution |
| 2703-6135 | PSA , φ17 × 150mm | In distribution |
| 2703-6172 | PSA,Ø 11×240 mm | In distribution |
| 2703-6124 | PSA, φ15×100mm | In distribution |
| 2703-6015 | PSA, φ18×75mm | In distribution |
| 2703-6031 | PSA , φ10 × 150mm | In distribution |
| 2304-2430 | UC, #3 | In distribution |
| 2403-2020 | on set,3 pegs,small,φ29mm | In distribution |
| 2103-6240 | PSA, #4, right, | In distribution |
| 2303-2411 | UC, #1, 9mm, | In distribution |
| 2303-4021 | PS, #2, 9mm, | In distribution |
| 2203-6060 | PSA, #6 | In distribution |
| 2603-6041 | #4, 4mm | In distribution |
| 2303-2211 | CR, plained, #1, 9mm | In distribution |
| 2703-6013 | PSA, φ14×75mm | In distribution |
| 2303-2263 | CR, plained, #6, 13mm | In distribution |
| 2703-6154 | PSA, ψ15 x 150mm | In distribution |
| 2104-2115 | #1.5, left | In distribution |
| 2103-2140 | CR, #4, left, | In distribution |
| 2703-6114 | PSA, φ15×75mm | In distribution |
| 2104-2120 | #2, left | In distribution |
| 2703-6134 | PSA , φ15 × 150mm | In distribution |
| 2303-2232 | Knee tibia trial prosthesis | In distribution |
| 2303-4014 | PS, #1, 15mm, | In distribution |
| 2703-6148 | PSA , φ23 × 200mm | In distribution |
| 2204-4010 | #1 | In distribution |
| 2304-2460 | UC, #6 | In distribution |
| 2703-6137 | PSA , φ21 × 150mm | In distribution |
| 2303-2422 | UC, #2, 11mm, | In distribution |
| 2603-6353 | distal only, #5, 12mm, | In distribution |
| 2204-4070 | #7 | In distribution |
| 2703-6144 | PSA , φ15 × 200mm | In distribution |
| 2203-4010-RA | #1 | In distribution |
| 2304-2450 | UC, #5 | In distribution |
| 2703-6067 | PSA,Ø 22×200 mm | In distribution |
| 9403-6031 | L | In distribution |
| 2703-6048 | PSA , φ24 × 200mm | In distribution |
| 2703-6131 | PSA , φ9 × 150mm | In distribution |
| 2303-2213 | CR, plained, #1, 11mm | In distribution |
| 9403-7311 | 9mm | In distribution |
| 2703-6142 | PSA , φ11 × 200mm | In distribution |
| 2703-6153 | PSA, ψ13 x 150mm | In distribution |
| 2304-2470 | UC, #7 | In distribution |
| 2303-2265 | CR, plained, #6, 18mm | In distribution |
| 2103-2160 | CR, #6, left, | In distribution |
| 2203-6040 | PSA, #4 | In distribution |
| 2403-2070 | on set, 3 pegs, E-large, φ44mm | In distribution |
| 2703-6143 | PSA , φ13 × 200mm | In distribution |
| 2703-6115 | PSA, φ17×75mm | In distribution |
| 2304-2440 | UC, #4 | In distribution |
| 2103-4270 | PS, #7, right, | In distribution |
| 2603-6323 | distal only, #2, 12mm, | In distribution |
| 2103-6120 | PSA, #2, left, | In distribution |
| 2303-2431 | UC, #3, 9mm, | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252725 | 2025-09-25 |
| K243024 | 2024-12-20 |
| K222700 | 2022-10-06 |
| K210961 | 2021-04-21 |
| K161705 | 2017-03-16 |
| K161360 | 2017-02-01 |
| K152430 | 2016-04-12 |
| K150829 | 2015-09-25 |
| K140073 | 2014-06-16 |
| K132752 | 2014-03-13 |
| K131864 | 2014-01-15 |
| K131116 | 2013-10-30 |
| K122183 | 2013-02-05 |
| K120507 | 2012-05-04 |
| K103733 | 2011-08-02 |
| K100981 | 2010-06-14 |
| K082424 | 2008-12-16 |
| K082469 | 2008-09-26 |
| K051640 | 2006-03-01 |
| K021657 | 2002-08-12 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Orthopedic Alliance, LLC | 510(k) number | 2013-02-20 | Class II | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. | 136 units | 2014-03-26 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 | |
| 2017-11-24 | Class II | Labeling mix-ups | UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling. | 14 pieces | 2018-10-09 |
| 2017-11-24 | Class II | Labeling mix-ups | UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling. | 69 pieces | 2018-10-09 |
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.