DynaFORCE™ HiMax
16 catalogue numbers from DynaFORCE HiMAX Single Packaged Implant , listed by Crossroads Extremity Systems LLC, United States, under Staple, Fixation, Bone. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
16catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Guangdong (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Crossroads Extremity Systems LLC, United States |
|---|---|
| FDA product code | JDR |
| Device type | Staple, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K142727 |
| Record published | 2020-03-20 |
| Record revised | 2026-03-09 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DynaFORCE HiMAX Single Packaged Implant 20mm x 16mm x 14mm | In distribution | |
| DynaFORCE HiMAX Single Packaged Implant 25mm x 18mm x 14mm | In distribution | |
| 7115-1818 | In distribution | |
| 7115-1515 | In distribution | |
| DynaFORCE HiMAX Single Packaged Implant 18mm x 18mm x 14mm | In distribution | |
| 7120-2020 | In distribution | |
| 7125-2222 | In distribution | |
| DynaFORCE HiMAX Single Packaged Implant 25mm x 16mm x 14mm | In distribution | |
| DynaFORCE HiMAX Single Packaged Implant 25mm x 18mm x 18mm | In distribution | |
| DynaFORCE HiMAX Single Packaged Implant 15mm x 12mm x 12mm | In distribution | |
| 7118-1414 | In distribution | |
| 7118-2020 | In distribution | |
| DynaFORCE HiMAX Single Packaged Implant 20mm x 18mm x 18mm | In distribution | |
| DynaFORCE HiMAX Single Packaged Implant 20mm x 14mm x 14mm | In distribution | |
| DynaFORCE HiMAX Single Packaged Implant 20mm x 18mm x 14mm | In distribution | |
| 7118-1818 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DynaBridge | Fusion Orthopedics, LLC | 156 |
| Arthrex® | Arthrex, Inc. | 80 |
| Staple, Fixation, Bone | Smith & Nephew, Inc. | 59 |
| Compression Staple System | Tornier Inc. | 36 |
| UNI-Clip | Newdeal Sas | 35 |
| Z-Staple | Z-Medical Gmbh & Co. KG | 34 |
| Orbitum Staple System | CPM Medical Consultants, LLC. | 32 |
| OSStaple | Biomedical Enterprises, Inc. | 30 |
| Acumed | Acumed LLC | 30 |
| Stealthfix Intraosseous Fixation System | Medartis Inc. | 29 |
| Staple, Fixation, Bone | Stryker GmbH | 29 |
| Step Boss | Biomedical Enterprises, Inc. | 27 |
Showing 12 of 319. All products under Staple, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181866 | 2018-08-09 |
| K181410 | 2018-06-29 |
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 |
|---|---|---|---|---|---|---|---|
| Crossroads Extremity Systems LLC | 510(k) number | 2017-02-16 | Class II | Labeling mix-ups | Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm. | 20 units | 2017-04-27 |
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.