U2 Total Knee System
Onset patellar reamer, XL/XXL, Ø46mm
23manufacturers in China registered for this device type
40catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (6), Zhejiang (3). 8 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 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Changzhou Master Precision Tool Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Showing 12 of 23. All 23 manufacturers in China registered for Reamer
Record
| Listed by | United Orthopedic Corp., Taiwan |
|---|---|
| FDA product code | HTO |
| Device type | Reamer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-04-29 |
| Record revised | 2023-10-04 (version 3) |
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 |
|---|---|---|
| 9323-3510 | In distribution | |
| 9323-3614 | In distribution | |
| 9323-3515 | In distribution | |
| 9323-3609 | In distribution | |
| 9323-3514 | In distribution | |
| 9323-3523 | In distribution | |
| 9323-3611 | In distribution | |
| 9304-3101 | In distribution | |
| 9323-3524 | In distribution | |
| 9404-4715-TB | In distribution | |
| 9303-3205-RT | In distribution | |
| 9323-3612 | In distribution | |
| 9323-3617 | In distribution | |
| 9404-4713-TB | In distribution | |
| 9323-3623 | In distribution | |
| 9323-3621 | In distribution | |
| 9323-3519 | In distribution | |
| 9323-3521 | In distribution | |
| 9323-3512 | In distribution | |
| 9323-3518 | In distribution | |
| 9323-3509 | In distribution | |
| 9323-3516 | In distribution | |
| 9304-4101-RE | In distribution | |
| 9304-3108-RA | In distribution | |
| 9323-3511 | In distribution | |
| 9323-3616 | In distribution | |
| 9323-3520 | In distribution | |
| 9323-3622 | In distribution | |
| 9304-3105 | In distribution | |
| 9404-4714-TB | In distribution | |
| 9323-3513 | In distribution | |
| 9323-3517 | In distribution | |
| 9323-3610 | In distribution | |
| 9323-3613 | In distribution | |
| 9323-3619 | In distribution | |
| 9323-3522 | In distribution | |
| 9323-3615 | In distribution | |
| 9304-3108 | In distribution | |
| 9323-3620 | In distribution | |
| 9323-3618 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trigen | Smith & Nephew, Inc. | 1,029 |
| Viant Medical, LLC | Viant Medical, LLC | 825 |
| R3 | Smith & Nephew, Inc. | 287 |
| Reamer | Ortho Development Corp. | 259 |
| InSitu Hip System | Nextstep Arthropedix | 181 |
| Apex Knee System | Omni Life Science, Inc. | 162 |
| Reamer | Synthes Gmbh | 152 |
| Reclaim | Depuy (Ireland) | 138 |
| Reamer | Zimmer, Inc. | 135 |
| Endo-Model Knee System – Instruments | Waldemar Link GmbH & Co. KG | 109 |
| DJO Surgical | Encore Medical, L.P. | 108 |
| Arthrex® | Arthrex, Inc. | 105 |
Showing 12 of 1,224. All products under Reamer
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.