Arthrex®
Reamer, Metatrsl MTP PLT, Reusable, 16MM
23manufacturers in China registered for this device type
105catalogue numbers in this listing
1recall
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 | Arthrex, Inc., United States |
|---|---|
| FDA product code | HTO |
| Device type | Reamer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-07-14 |
| Record revised | 2023-10-04 (version 6) |
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, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-4158PR-08C | In distribution | |
| AR-8944MR-16RU | In distribution | |
| AR-4158PR-10C-RU | In distribution | |
| AR-9091-20 | In distribution | |
| AR-9097-02-RU | In distribution | |
| AR-9091-14 | In distribution | |
| AR-9095R-135 | In distribution | |
| AR-9095FR-130 | In distribution | |
| AR-9095-69-RU | In distribution | |
| AR-8974-26 | In distribution | |
| AR-9095FR-125 | In distribution | |
| AR-4158PR-12V | In distribution | |
| AR-8944MR-18RU | In distribution | |
| AR-8944MC-20RU | In distribution | |
| AR-9095R-110 | In distribution | |
| AR-8974-28 | In distribution | |
| AR-9099-02 | In distribution | |
| AR-8973-32LS | In distribution | |
| AR-9091-10 | In distribution | |
| AR-9095R-155 | In distribution | |
| AR-9091-05 | In distribution | |
| AR-4158PR-12C | In distribution | |
| AR-9095R-090 | In distribution | |
| AR-9095R-105 | In distribution | |
| AR-602-19 | In distribution | |
| AR-9095R-095 | In distribution | |
| AR-8974-62S | In distribution | |
| AR-4158PR-12V-RU | In distribution | |
| AR-4158PR-08V-RU | In distribution | |
| AR-9091-15 | In distribution | |
| AR-8944MR-14RU | In distribution | |
| AR-8944MR-22RU | In distribution | |
| AR-8944MC-16RU | In distribution | |
| AR-9095FR-145 | In distribution | |
| AR-9095FR-150 | In distribution | |
| AR-9091-08 | In distribution | |
| AR-8974-40LS | In distribution | |
| AR-8974-50S | In distribution | |
| AR-9097-02 | In distribution | |
| AR-9095R-120 | In distribution | |
| AR-8944PR-16RU | In distribution | |
| AR-9095R-150 | In distribution | |
| AR-4158PR-06C-RU | In distribution | |
| AR-9095FR-165 | In distribution | |
| AR-9095R-165 | In distribution | |
| AR-9095R-01 | In distribution | |
| AR-9095FR-85 | In distribution | |
| AR-8974-32XLS | In distribution | |
| AR-9091-09 | In distribution | |
| AR-9095FR-100 | In distribution | |
| AR-9095R-140 | In distribution | |
| AR-9091-07 | In distribution | |
| AR-8944PR-18RU | In distribution | |
| AR-9091-12 | In distribution | |
| AR-9095FR-155 | In distribution | |
| AR-602-17 | In distribution | |
| AR-4158PR-08C-RU | In distribution | |
| AR-9095R-130 | In distribution | |
| AR-8944PR-20RU | In distribution | |
| AR-9091-06 | In distribution | |
| AR-9095-69 | In distribution | |
| AR-9095FR-135 | In distribution | |
| AR-9095FR-105 | In distribution | |
| AR-9091-11 | In distribution | |
| AR-9091-04 | In distribution | |
| AR-9095-01 | In distribution | |
| AR-4158PR-10V-RU | In distribution | |
| AR-8973-40S | In distribution | |
| AR-8974-32S | In distribution | |
| AR-8944MC-18RU | In distribution | |
| AR-9095-01-RU | In distribution | |
| AR-8973-40LS | In distribution | |
| AR-8944PR-14RU | In distribution | |
| AR-4158PR-08V | In distribution | |
| AR-9095FR-115 | In distribution | |
| AR-4158PR-12C-RU | In distribution | |
| AR-602-16 | In distribution | |
| AR-8944MC-22RU | In distribution | |
| AR-9095FR-80 | In distribution | |
| AR-8974-50 | In distribution | |
| AR-9095R-145 | In distribution | |
| AR-4158PR-06C | In distribution | |
| AR-9095R-100 | In distribution | |
| AR-9099-23 | In distribution | |
| AR-8974-28S | In distribution | |
| AR-9095R-115 | In distribution | |
| AR-4158PR-06V-RU | In distribution | |
| AR-9095FR-140 | In distribution | |
| AR-8974-32LS | In distribution | |
| AR-4158PR-06V | In distribution | |
| AR-4158PR-10V | In distribution | |
| AR-4158PR-10C | In distribution | |
| AR-8944MR-20RU | In distribution | |
| AR-9099-02-RU | In distribution | |
| AR-8944MC-14RU | In distribution | |
| AR-9095FR-120 | In distribution | |
| AR-9091-13 | In distribution | |
| AR-8974-26S | In distribution | |
| AR-602-18 | In distribution | |
| AR-8944PR-22RU | In distribution | |
| AR-9095R-125 | In distribution | |
| AR-9095FR-75 | In distribution | |
| AR-9091-03 | In distribution | |
| AR-9095FR-110 | In distribution | |
| AR-8974-40S | 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 | Provision | 98 |
Showing 12 of 1,224. All products under Reamer
Recalls
1 of these is 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 |
|---|---|---|---|---|
| 2018-09-13 | Class II | Software change control | There is potential to break during use. | 832 |
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.