Acumed
Biotrak® Arthroscopic Cannula Handle
12manufacturers in China registered for this device type
25catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Acumed LLC, United States |
|---|---|
| FDA product code | HTY |
| Device type | Pin, Fixation, Smooth |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K964500 |
| Record published | 2015-10-24 |
| Record revised | 2025-07-14 (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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature up to 120 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30100320 | In distribution | |
| 30-0099 | In distribution | |
| 30-0097 | In distribution | |
| 30150106 | In distribution | |
| TB-1570K-S | In distribution | |
| 30150107 | In distribution | |
| 30100340 | In distribution | |
| 47-0001-S | In distribution | |
| 47-0002-S | In distribution | |
| 30100108 | In distribution | |
| 30-0166 | In distribution | |
| TB-1550K-S | In distribution | |
| 47-0003-S | In distribution | |
| 30100330 | In distribution | |
| 30-0096K-S | In distribution | |
| 30100352 | In distribution | |
| 80-2150 | In distribution | |
| 30-0167 | In distribution | |
| 30-0094K-S | In distribution | |
| 80-0411 | In distribution | |
| 30-0168 | In distribution | |
| TB-15120K-S | In distribution | |
| TB-1590K-S | In distribution | |
| 30-0098 | In distribution | |
| 30-0095K-S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rondo’ | Citieffe SRL | 265 |
| HNM Medical | HNM Stainless, LLC. | 232 |
| Kmedic | Teleflex Medical LLC | 227 |
| gSource | Gsource, LLC. | 221 |
| MicroAire® | Microaire Surgical Instruments LLC | 213 |
| Orthomed | Ortho-MED, Inc. | 163 |
| mahe medical GmbH | Mahe Intl., Inc. | 160 |
| Pin, Fixation, Smooth | Key Surgical, LLC | 134 |
| Pin, Fixation, Smooth | Stryker GmbH | 134 |
| Aptus | Medartis Inc. | 134 |
| Key Surgical K-Wires and Steinmann Pins | Key Surgical, LLC | 126 |
| PedFlex Flexible Nailing System | Orthopediatrics, Corp | 119 |
Showing 12 of 682. All products under Pin, Fixation, Smooth
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 |
|---|---|---|---|---|---|---|---|
| Acumed LLC | 510(k) number | 2014-03-26 | Class II | Component change control | Manufacturing of these devices with a grade of stainless steel that is not within specifications. | 141 units in the US; 294 units outside the US. | 2015-02-04 |
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.