U2™ Knee
Femoral distal augment trial, LM/RL, #5, 8mm
12manufacturers in China registered for this device type
102catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 8 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| 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 | MBH |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3565 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K122183 |
| Record published | 2017-05-23 |
| Record revised | 2022-09-16 (version 10) |
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 |
|---|---|---|
| 2303-6058 | PSA, #5, 30mm, | In distribution |
| 2803-6223 | #2, 15mm, right, | In distribution |
| 2204-4040 | #4 | In distribution |
| 2303-6066 | PSA, #6, 21mm, | In distribution |
| 2203-4060-RB | #6 | In distribution |
| 2204-4030-RA | #3 | In distribution |
| 2303-2215 | CR, plained, #1, 18mm | In distribution |
| 2303-6054 | PSA, #5, 15mm, | In distribution |
| 2204-4070-RA | #7 | In distribution |
| 2803-6102 | #0, 10mm, left, | In distribution |
| 2803-6272 | #7, 10mm, right, | In distribution |
| 2803-6113 | #1, 15mm, left, | In distribution |
| 2203-4010-RB | #1 | In distribution |
| 2803-6231 | #3, 5mm, right, | In distribution |
| 2303-6068 | PSA, #6, 30mm, | In distribution |
| 2803-6161 | #6, 5mm, left, | In distribution |
| 2303-6014 | PSA, #1, 15mm, | In distribution |
| 2603-6152 | LM/RL, #5, 8mm, | In distribution |
| 9303-8074 | In distribution | |
| 2303-4064 | PS, #6, 15mm, | In distribution |
| 2204-4020 | #2 | In distribution |
| 2204-4000 | #0 | In distribution |
| 9303-8030-RA | In distribution | |
| 2303-4075 | PS, #7, 18mm, | In distribution |
| 2303-4042 | PS, #4, 11mm, | In distribution |
| 2803-6211 | #1, 5mm, right, | In distribution |
| 2803-6141 | #4, 5mm, left, | In distribution |
| 2803-6133 | #3, 15mm, left, | In distribution |
| 2603-6051 | #5, 4mm | In distribution |
| 9303-8020 | In distribution | |
| 9303-8075 | In distribution | |
| 2803-6201 | #0, 5mm, right, | In distribution |
| 2303-6022 | PSA, #2, 11mm, | In distribution |
| 2303-4051 | PS, #5, 9mm, | In distribution |
| 2303-4071 | PS, #7, 9mm, | In distribution |
| 9303-8053 | In distribution | |
| 2603-6162 | LM/RL, #6, 8mm, | In distribution |
| 2603-6121 | LM/RL, #2, 4mm, | In distribution |
| 2603-6222 | RM/LL, #2, 8mm, | In distribution |
| 2303-6016 | PSA, #1, 21mm, | In distribution |
| 2303-6024 | PSA, #2, 15mm, | In distribution |
| 2603-6242 | RM/LL, #4, 8mm, | In distribution |
| 2303-6048 | PSA, #4, 30mm, | In distribution |
| 2803-6251 | #5, 5mm, right, | In distribution |
| 2803-6262 | #6, 10mm, right, | In distribution |
| 9303-8073 | In distribution | |
| 2303-4055 | PS, #5, 18mm, | In distribution |
| 2303-4044 | PS, #4, 15mm, | In distribution |
| 2303-6044 | PSA, #4, 15mm, | In distribution |
| 2303-6038 | PSA, #3, 30mm, | In distribution |
| 2603-6131 | LM/RL, #3, 4mm, | In distribution |
| 2303-6042 | PSA, #4, 11mm, | In distribution |
| 2203-4030-RB | #3 | In distribution |
| 2803-6151 | #5, 5mm, left, | In distribution |
| 2303-6012 | PSA, #1, 11mm, | In distribution |
| 2603-6151 | LM/RL, #5, 4mm, | In distribution |
| 2603-6232 | RM/LL, #3, 8mm, | In distribution |
| 2303-4033 | PS, #3, 13mm, | In distribution |
| 2803-6101 | #0, 5mm, left, | In distribution |
| 2303-4062 | PS, #6, 11mm, | In distribution |
| 2803-6121 | #2, 5mm, left, | In distribution |
| 2303-6062 | PSA, #6, 11mm, | In distribution |
| 2303-6028 | PSA, #2, 30mm, | In distribution |
| 2303-6052 | PSA, #5, 11mm, | In distribution |
| 9303-8072 | In distribution | |
| 2204-4060 | #6 | In distribution |
| 2803-6202 | #0, 10mm, right, | In distribution |
| 2803-6241 | #4, 5mm, right, | In distribution |
| 2303-6026 | PSA, #2, 21mm, | In distribution |
| 2303-6034 | PSA, #3, 15mm, | In distribution |
| 2303-6046 | PSA, #4, 21mm, | In distribution |
| 2603-6111 | LM/RL, #1, 4mm, | In distribution |
| 2903-2010 | 2mm | In distribution |
| 2303-4031 | PS, #3, 9mm, | In distribution |
| 2403-2010 | on set,3 pegs,X-small,φ26mm | In distribution |
| 2803-6253 | #5, 15mm, right, | In distribution |
| 2803-6233 | #3, 15mm, right, | In distribution |
| 2303-4053 | PS, #5, 13mm, | In distribution |
| 2603-6212 | RM/LL, #1, 8mm, | In distribution |
| 2603-6061 | #6, 4mm | In distribution |
| 2803-6111 | #1, 5mm, left, | In distribution |
| 2803-6221 | #2, 5mm, right, | In distribution |
| 2303-6056 | PSA, #5, 21mm, | In distribution |
| 2204-4010-RA | #1 | In distribution |
| 2803-6163 | #6, 15mm, left, | In distribution |
| 2303-6036 | PSA, #3, 21mm, | In distribution |
| 9303-8010 | In distribution | |
| 2204-4050-RA | #5 | In distribution |
| 2803-6131 | #3, 5mm, left, | In distribution |
| 9303-8040-RA | In distribution | |
| 2303-4022 | PS, #2, 11mm, | In distribution |
| 2903-2030 | 6mm | In distribution |
| 2303-6018 | PSA, #1, 30mm, | In distribution |
| 2303-6064 | PSA, #6, 15mm, | In distribution |
| 2803-6171 | #7, 5mm, left, | In distribution |
| 2303-4024 | PS, #2, 15mm, | In distribution |
| 2303-4073 | PS, #7, 13mm, | In distribution |
| 2303-6032 | PSA, #3, 11mm, | In distribution |
| 2603-6141 | LM/RL, #4, 4mm, | In distribution |
| 2303-4035 | PS, #3, 18mm, | In distribution |
| 9303-8076 | In distribution | |
| 9303-8071-RA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 4,272 |
| Triathlon | Howmedica Osteonics Corp | 712 |
| Instrument | Howmedica Osteonics Corp | 709 |
| Persona® Vivacit-E® | Zimmer, Inc. | 499 |
| Arthrex® | Arthrex, Inc. | 494 |
| Persona® | Zimmer, Inc. | 441 |
| Legion | Smith & Nephew, Inc. | 397 |
| U2 Total Knee System | United Orthopedic Corp. | 286 |
| Attune | Depuy (Ireland) | 234 |
| DJO Surgical | Encore Medical, L.P. | 191 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 150 |
| Truliant® | Exactech, Inc. | 142 |
Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243656 | 2025-07-31 |
| K221705 | 2023-02-28 |
| K150832 | 2015-09-25 |
| K140075 | 2014-06-13 |
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.