TriMAX Implant System
The TriMAX Implant System is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone fragment osteotomy fixation and joint arthrodesis.
7manufacturers in China registered for this device type
12catalogue 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 |
| Record published | 2019-09-17 |
| Record revised | 2026-02-09 (version 10) |
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 |
|---|---|---|
| TriMAX 18mm Full Prep Kit | 20mm x 20mm x 20mm | In distribution |
| TriMAX Single Packaged Implant, 20mm x 20mm | In distribution | |
| TriMAX 25mm Full Prep Kit | In distribution | |
| TriMAX Single Packaged Implant, 18mm x 18mm | In distribution | |
| TriMAX 25mm Prep Kit | In distribution | |
| TriMAX 20mm Full Prep Kit | In distribution | |
| TriMAX 18mm Prep Kit | In distribution | |
| TriMAX Single Packaged Implant, 18mm x 14mm | 18mm x 14mm | In distribution |
| TriMAX Single Packaged Implant, 18mm x 20mm | 18mm x 20mm | In distribution |
| TriMAX 20mm Prep Kit | In distribution | |
| TriMAX Single Packaged Implant, 18mm x 22mm | 18mm x 22mm | In distribution |
| TriMAX Single Packaged Implant, 25mm x 22mm | 25mm x 22mm | 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
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 | Closed |
|---|---|---|---|---|---|
| 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.