U2™ Knee
Patellar trial, on set, 3 pegs, XX-large, φ41mm
8manufacturers in China registered for this device type
195catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 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 |
| 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 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | United Orthopedic Corp., Taiwan |
|---|---|
| FDA product code | OIY |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K120507 |
| Record published | 2017-05-20 |
| Record revised | 2022-03-22 (version 7) |
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 |
|---|---|---|
| 2103-2250 | CR, #5, right, | In distribution |
| 9403-7312 | 9mm | In distribution |
| 2204-4060-RA | #6 | In distribution |
| 2303-2253 | CR, plained, #5, 13mm | In distribution |
| 2303-2242 | CR, plained, #4, 11mm | In distribution |
| 2603-6314 | distal only, #1, 16mm, | In distribution |
| 2303-2412 | UC, #1, 11mm, | In distribution |
| 2104-2270 | #7, right | In distribution |
| 2303-2212 | CR, plained, #1, 11mm | In distribution |
| 2603-6112 | LM/RL, #1, 8mm, | In distribution |
| 2103-4130 | PS, #3, left, | In distribution |
| 2903-2020 | 4mm | In distribution |
| 2203-4040-RA | #4 | In distribution |
| 2603-6161 | LM/RL, #6, 4mm, | In distribution |
| 2404-2010 | in set | In distribution |
| 2303-4025 | PS, #2, 18mm, | In distribution |
| 2303-2255 | CR, plained, #5, 18mm | In distribution |
| 2603-6062 | #6, 8mm | In distribution |
| 2104-2165 | #6.5, left | In distribution |
| 2403-2030 | on set,3 pegs,medium,φ32mm | In distribution |
| 2703-6042 | PSA , φ12 × 200mm | In distribution |
| 2403-2050 | on set,3 pegs,X-large,φ38mm | In distribution |
| 2703-6012 | PSA, φ12×75mm | In distribution |
| 2303-2421 | UC, #2, 9mm, | In distribution |
| 2803-6252 | #5, 10mm, right, | In distribution |
| 2303-6023 | PSA, #2, 13mm, | In distribution |
| 2303-2425 | UC, #2, 18mm, | In distribution |
| 2104-2135 | #3.5, left | In distribution |
| 2603-6251 | RM/LL, #5, 4mm, | In distribution |
| 2104-2110 | #1, left | In distribution |
| 2303-2233 | CR, plained, #3, 13mm | In distribution |
| 2603-6344 | distal only, #4, 16mm, | In distribution |
| 2703-6036 | PSA , φ20 × 150mm | In distribution |
| 2303-4045 | PS, #4, 18mm, | In distribution |
| 2603-6211 | RM/LL, #1, 4mm, | In distribution |
| 9403-7314 | 15mm | In distribution |
| 2103-2170 | CR, #7, left, | In distribution |
| 9403-7310 | #1 | In distribution |
| 2303-2221 | CR, plained, #2, 9mm | In distribution |
| 2104-2250 | #5, right | In distribution |
| 2303-2474 | UC, #7, 15mm, | In distribution |
| 2303-4013 | PS, #1, 13mm, | In distribution |
| 2303-6021 | PSA, #2, 9mm, | In distribution |
| 2303-6015 | PSA, #1, 18mm, | In distribution |
| 2303-4034 | PS, #3, 15mm, | In distribution |
| 2803-6172 | #7, 10mm, left, | In distribution |
| 2303-6063 | PSA, #6, 13mm, | In distribution |
| 2303-2441 | UC, #4, 9mm, | In distribution |
| 2303-2222 | CR, plained, #2, 11mm | In distribution |
| 2703-6026 | PSA, φ20×100mm | In distribution |
| 2204-4000-RA | #0 | In distribution |
| 2803-6143 | #4, 15mm, left, | In distribution |
| 2104-2155 | #5.5, left | In distribution |
| 2303-6027 | PSA, #2, 25mm, | In distribution |
| 2303-6053 | PSA, #5, 13mm, | In distribution |
| 2303-6033 | PSA, #3, 13mm, | In distribution |
| 2303-4023 | PS, #2, 13mm, | In distribution |
| 2103-2150 | CR, #5, left, | In distribution |
| 2703-6066 | PSA,Ø 20×200 mm | In distribution |
| 2803-6242 | #4, 10mm, right, | In distribution |
| 2803-6263 | #6, 15mm, right, | In distribution |
| 2803-6112 | #1, 10mm, left, | In distribution |
| 2803-6142 | #4, 10mm, left, | In distribution |
| 2303-4074 | PS, #7, 15mm, | In distribution |
| 2104-2240 | #4, right | In distribution |
| 2203-4060-RA | #6 | In distribution |
| 2103-4240 | PS, #4, right, | In distribution |
| 2303-2273 | CR, plained, #7, 13mm | In distribution |
| 2603-6052 | #5, 8mm | In distribution |
| 2603-6122 | LM/RL, #2, 8mm, | In distribution |
| 2603-6324 | distal only, #2, 16mm, | In distribution |
| 2103-6230 | PSA, #3, right, | In distribution |
| 2303-2414 | UC, #1, 15mm, | In distribution |
| 2103-4150 | PS, #5, left, | In distribution |
| 2303-4032 | PS, #3, 11mm, | In distribution |
| 2303-2235 | CR, plained, #3, 18mm | In distribution |
| 9403-7330 | #3 | In distribution |
| 2703-6052 | PSA, ψ12 x 150mm | In distribution |
| 2303-6017 | PSA, #1, 25mm, | In distribution |
| 2703-6064 | PSA,Ø16 x200 mm | In distribution |
| 2303-2271 | CR, plained, #7, 9mm | In distribution |
| 2603-6012 | #1, 8mm | In distribution |
| 2703-6014 | PSA, φ16×75mm | In distribution |
| 2303-4011 | PS, #1, 9mm, | In distribution |
| 2303-4052 | PS, #5, 11mm, | In distribution |
| 2303-6067 | PSA, #6, 25mm, | In distribution |
| 2603-6252 | RM/LL, #5, 8mm, | In distribution |
| 2703-6016 | PSA, φ20×75mm | In distribution |
| 9403-7350 | #5 | In distribution |
| 2203-6010 | PSA, #1 | In distribution |
| 2303-6047 | PSA, #4, 25mm, | In distribution |
| 2803-6213 | #1, 15mm, right, | In distribution |
| 2303-6065 | PSA, #6, 18mm, | In distribution |
| 2603-6022 | #2, 8mm | In distribution |
| 2303-4072 | PS, #7, 11mm, | In distribution |
| 2404-2000 | on set, 3 pegs | In distribution |
| 2104-2255 | #5.5, right | In distribution |
| 2204-4020-RA | #2 | In distribution |
| 2103-4170 | PS, #7, left, | In distribution |
| 2303-2432 | UC, #3, 11mm, | In distribution |
| 9403-6021 | M | In distribution |
| 2703-6044 | PSA , φ16 × 200mm | In distribution |
| 2303-2443 | UC, #4, 13mm, | In distribution |
| 2703-6062 | PSA,Ø 12×200 mm | In distribution |
| 2303-2262 | CR, plained, #6, 11mm | In distribution |
| 2603-6142 | LM/RL, #4, 8mm, | In distribution |
| 2103-6210 | PSA, #1, right, | In distribution |
| 2303-6043 | PSA, #4, 13mm, | In distribution |
| 9403-6020 | M | In distribution |
| 2803-6222 | #2, 10mm, right, | In distribution |
| 2104-2210 | #1, right | In distribution |
| 2303-4015 | PS, #1, 18mm, | In distribution |
| 2703-6032 | PSA , φ12 × 150mm | In distribution |
| 2703-6022 | PSA, φ12×100mm | In distribution |
| 2203-4070-RA | #7 | In distribution |
| 2104-2145 | #4.5, left | In distribution |
| 2803-6123 | #2, 15mm, left, | In distribution |
| 2103-2230 | CR, #3, right, | In distribution |
| 2303-6041 | PSA, #4, 9mm, | In distribution |
| 9403-6010 | S | In distribution |
| 2303-2251 | CR, plained, #5, 9mm | In distribution |
| 2603-6221 | RM/LL, #2, 4mm, | In distribution |
| 2803-6153 | #5, 15mm, left, | In distribution |
| 2303-2445 | UC, #4, 18mm, | In distribution |
| 2303-4054 | PS, #5, 15mm, | In distribution |
| 2103-4220 | PS, #2, right, | In distribution |
| 2803-6243 | #4, 15mm, right, | In distribution |
| 2103-4110 | PS, #1, left, | In distribution |
| 2303-4041 | PS, #4, 9mm, | In distribution |
| 2303-6025 | PSA, #2, 18mm, | In distribution |
| 2203-4020-RA | #2 | In distribution |
| 2103-2130 | CR, #3, left, | In distribution |
| 2103-2110 | CR, #1, left, | In distribution |
| 2103-6130 | PSA, #3, left, | In distribution |
| 2303-4061 | PS, #6, 9mm, | In distribution |
| 2103-2210 | CR, #1, right, | In distribution |
| 2603-6042 | #4, 8mm | In distribution |
| 2703-6046 | PSA , φ20 × 200mm | In distribution |
| 9403-7318 | 30mm | In distribution |
| 2603-6354 | Femoral augment trial, distal only, #5, 16mm | In distribution |
| 2303-2472 | UC, #7, 11mm, | In distribution |
| 2703-6034 | PSA , φ16 × 150mm | In distribution |
| 2603-6032 | #3, 8mm | In distribution |
| 2303-6057 | PSA, #5, 25mm, | In distribution |
| 2803-6152 | #5, 10mm, left, | In distribution |
| 2303-2231 | CR, plained, #3, 9mm | In distribution |
| 2303-2264 | CR, plained, #6, 15mm | In distribution |
| 2703-6024 | PSA, φ16×100mm | In distribution |
| 2303-6055 | PSA, #5, 18mm, | In distribution |
| 2103-6250 | PSA, #5, right, | In distribution |
| 2303-6051 | PSA, #5, 9mm, | In distribution |
| 2103-4260 | PS, #6, right, | In distribution |
| 2403-2060 | on set, 3 pegs, XX-large, φ41mm | In distribution |
| 2303-2224 | CR, plained, #2, 15mm | In distribution |
| 2803-6132 | #3, 10mm, left, | In distribution |
| 2703-6056 | PSA, ψ20 x 150mm | In distribution |
| 2104-2230 | #3, right | In distribution |
| 2203-6050 | PSA, #5 | In distribution |
| 2803-6232 | #3, 10mm, right, | In distribution |
| 2303-2461 | UC, #6, 9mm, | In distribution |
| 2303-6037 | PSA, #3, 25mm, | In distribution |
| 2303-6061 | PSA, #6, 9mm, | In distribution |
| 2303-4063 | PS, #6, 13mm, | In distribution |
| 2303-4065 | PS, #6, 18mm, | In distribution |
| 2303-2423 | UC, #2, 13mm, | In distribution |
| 2104-2220 | #2, right | In distribution |
| 2603-6334 | distal only, #3, 16mm, | In distribution |
| 2103-6110 | PSA, #1, left, | In distribution |
| 2803-6162 | #6, 10mm, left, | In distribution |
| 2303-6011 | PSA, #1, 9mm, | In distribution |
| 2603-6262 | RM/LL, #6, 8mm, | In distribution |
| 2803-6122 | #2, 10mm, left, | In distribution |
| 2603-6132 | LM/RL, #3, 8mm, | In distribution |
| 2303-2434 | UC, #3, 15mm, | In distribution |
| 2103-6150 | PSA, #5, left, | In distribution |
| 2104-2265 | #6.5, right | In distribution |
| 2703-6054 | PSA, ψ16 x 150mm | In distribution |
| 2303-2244 | CR, plained, #4, 15mm | In distribution |
| 2603-6241 | RM/LL, #4, 4mm, | In distribution |
| 2303-6013 | PSA, #1, 13mm, | In distribution |
| 2303-2452 | UC, #5, 11mm, | In distribution |
| 2203-6030 | PSA, #3 | In distribution |
| 2303-2465 | UC, #6, 18mm, | In distribution |
| 2603-6231 | RM/LL, #3, 4mm, | In distribution |
| 2303-2454 | UC, #5, 15mm, | In distribution |
| 2303-2463 | UC, #6, 13mm, | In distribution |
| 9403-7316 | 21mm | In distribution |
| 2303-2275 | CR, plained, #7, 18mm | In distribution |
| 2303-6031 | PSA, #3, 9mm, | In distribution |
| 2303-4043 | PS, #4, 13mm, | In distribution |
| 2204-4040-RA | #4 | In distribution |
| 2303-6035 | PSA, #3, 18mm, | In distribution |
| 2703-6003 | PSA, φ14×30mm | In distribution |
| 2303-6045 | PSA, #4, 18mm, | In distribution |
| 2803-6212 | #1, 10mm, right, | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Persona® | Zimmer, Inc. | 552 |
| DJO Surgical | Encore Medical, L.P. | 415 |
| Genflex2 Total Knee System | Globus Medical, Inc. | 389 |
| Persona® Vivacit-E® | Zimmer, Inc. | 332 |
| Truliant, Activit-E | Exactech, Inc. | 272 |
| TriVerse Meniscal Insert PS | Signature Orthopaedics PTY Limited | 220 |
| BKS E-Vitalize | Ortho Development Corp. | 193 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 169 |
| Attune | Depuy (Ireland) | 161 |
| Vanguard Complete Knee System | Biomet Orthopedics | 153 |
| EXp Tibial Inserts and Patellar Components | Globus Medical, Inc. | 144 |
| TriVerse Meniscal Insert AS | Signature Orthopaedics PTY Limited | 126 |
Showing 12 of 102. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
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 |
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.