Instrument
22MM-25MM Reamers AND Stem Trials Triathlon Revision Instruments
23manufacturers in China registered for this device type
57catalogue numbers in this listing
4recalls on this code
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 | Howmedica Osteonics Corp, 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 |
| Premarket notification | Exempt |
| Record published | 2017-11-13 |
| Record revised | 2022-09-16 (version 8) |
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 |
| Sizes | Lumen/inner diameter 9 to 19 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I-K2762SB19 | Lumen/Inner Diameter 19.0 mm | In distribution |
| I-K27207516 | Diameter: 16.0 Millimeter | In distribution |
| I-K2762SB13 | Lumen/Inner Diameter 13.0 mm | In distribution |
| I-K2762SB09 | Lumen/Inner Diameter 9.0 mm | In distribution |
| I-K27207519 | Diameter: 19.0 Millimeter | In distribution |
| I-K2762SB11 | Lumen/Inner Diameter 11.0 mm | In distribution |
| I-K27207514 | Diameter: 14.0 Millimeter | In distribution |
| I-K2762SB17 | Lumen/Inner Diameter 17.0 mm | In distribution |
| 6543-7-510 | Diameter: 10.0 Millimeter | In distribution |
| 6543-7-527 | In distribution | |
| 6543-5-202 | Side: Right Medial/Left Lateral | In distribution |
| 6543-7-512 | Diameter: 12.0 Millimeter | In distribution |
| I-K27207525 | Diameter: 25.0 Millimeter | In distribution |
| I-K27207509 | Diameter: 9.0 Millimeter | In distribution |
| 6543-7-519 | Diameter: 19.0 Millimeter | In distribution |
| 6543-7-524 | Diameter: 24.0 Millimeter | In distribution |
| 6543-5-201 | Side: Left Medial/Right Lateral | In distribution |
| 6278-5-600 | In distribution | |
| I-K27207522 | Diameter: 22.0 Millimeter | In distribution |
| 6543-7-515 | Diameter: 15.0 Millimeter | In distribution |
| I-K27207521 | Diameter: 21.0 Millimeter | In distribution |
| I-K2762SB10 | Lumen/Inner Diameter 10.0 mm | In distribution |
| 6543-7-511 | Diameter: 11.0 Millimeter | In distribution |
| 6543-1-751 | In distribution | |
| 6543-7-509 | Diameter: 9.0 Millimeter | In distribution |
| I-K27207515 | Diameter: 15.0 Millimeter | In distribution |
| 6543-7-517 | Diameter: 17.0 Millimeter | In distribution |
| 6543-7-523 | Diameter: 23.0 Millimeter | In distribution |
| 6543-7-525 | Diameter: 25.0 Millimeter | In distribution |
| I-K27207512 | Diameter: 12.0 Millimeter | In distribution |
| I-K2762SB14 | Lumen/Inner Diameter 14.0 mm | In distribution |
| 6543-7-513 | Diameter: 13.0 Millimeter | In distribution |
| I-K27207513 | Diameter: 13.0 Millimeter | In distribution |
| 6543-7-521 | Diameter: 21.0 Millimeter | In distribution |
| I-K27207523 | Diameter: 23.0 Millimeter | In distribution |
| 6543-7-516 | Diameter: 16.0 Millimeter | In distribution |
| 6543-7-514 | Diameter: 14.0 Millimeter | In distribution |
| 6543-4-524 | Diameter: 24.0 Millimeter | In distribution |
| I-K27207518 | Diameter: 18.0 Millimeter | In distribution |
| 6543-7-518 | Diameter: 18.0 Millimeter | In distribution |
| I-K2762SB12 | Lumen/Inner Diameter 12.0 mm | In distribution |
| I-K27207517 | Diameter: 17.0 Millimeter | In distribution |
| I-K27207511 | Diameter: 11.0 Millimeter | In distribution |
| 6543-7-520 | Diameter: 20.0 Millimeter | In distribution |
| I-K2399PR20 | In distribution | |
| 6278-8-310 | Diameter: 10.0 Millimeter | In distribution |
| I-K27207510 | Diameter: 10.0 Millimeter | In distribution |
| 6543-8-108 | In distribution | |
| I-K2841BR00 | In distribution | |
| 6543-7-522 | Diameter: 22.0 Millimeter | In distribution |
| I-K3292BR00 | In distribution | |
| I-K27207524 | Diameter: 24.0 Millimeter | In distribution |
| I-K2762SB16 | Lumen/Inner Diameter 16.0 mm | In distribution |
| I-K27207520 | Diameter: 20.0 Millimeter | In distribution |
| 6543-6-019 | In distribution | |
| I-K2762SB15 | Lumen/Inner Diameter 15.0 mm | In distribution |
| I-K2762SB18 | Lumen/Inner Diameter 18.0 mm | 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
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-12-23 | Not classified | Device Design | A 46mm acetabular reamer was lasermarked as a 44m reamer and distributed to the field. | 134 units | 2013-07-17 |
| 2005-08-08 | Not classified | Device Design | Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly. | 22 | 2010-02-18 |
| 2005-08-08 | Not classified | Device Design | Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly. | 273 | 2010-02-18 |
| 2005-04-15 | Not classified | Process control | The Xcelerate Patella Reamer Shaft Assembly and the Reamer Adapter do not mate properly. This could result in the removal of excessive bone from the patella leading to a thinner patella; a patella that does not have enough bone for adequat | 24 total | 2008-09-24 |
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.