MotoCLIP/HiMAX Step Staple
The MotoCLIP/HiMAX Step Staple fixes bone fragments during hand and foot osteotomies and joint fusion. The nitinol staple is inserted with its legs held nearly parallel by the insertion…
The MotoCLIP/HiMAX Step Staple fixes bone fragments during hand and foot osteotomies and joint fusion. The nitinol staple is inserted with its legs held nearly parallel by the insertion device.
After release, the legs converge toward each other, creating compression across the adjoining bone. The system includes the implant and instruments needed to prepare and place it.
Listed Item
MotoCLIP/HiMAX Step Staple 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.
Implant Role
The staple provides internal fixation during reconstruction or management of bone fragments. Its superelastic metal construction supplies the compressive action after deployment, with implant size and offset selected for the planned hand or foot procedure.
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) | K181866 |
| Record published | 2018-11-12 |
| Record revised | 2021-11-23 (version 2) |
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 |
|---|---|---|
| Implant Kit, 18mm x 22mm x 24mm, 4mm Offset | 18mm x 22mm x 24mm, 4mm Offset | In distribution |
| Single Pack, 18mm x 22mm x 24mm, 8mm Offset | 18mm x 22mm x 24mm, 8mm Offset | In distribution |
| Single Pack, 18mm x 22mm x 24mm, 10mm Offset | 18mm x 22mm x 24mm, 10mm Offset | In distribution |
| Implant Kit, 18mm x 22mm x 24mm, 12mm Offset | 18mm x 22mm x 24mm, 12mm Offset | In distribution |
| Single Pack, 18mm x 22mm x 24mm, 4mm Offset | 18mm x 22mm x 24mm, 4mm Offset | In distribution |
| Single Pack, 18mm x 22mm x 24mm, 6mm Offset | 18mm x 22mm x 24mm, 6mm Offset | In distribution |
| Single Pack, 18mm x 22mm x 24mm, 12mm Offset | 18mm x 22mm x 24mm, 12mm Offset | In distribution |
| Implant Kit, 18mm x 22mm x 24mm, 10mm Offset | 18mm x 22mm x 24mm, 10mm Offset | In distribution |
| Step Staple Sterile Pack Prep Kit | In distribution | |
| Implant Kit, 18mm x 22mm x 24mm, 8mm Offset | 18mm x 22mm x 24mm, 8mm Offset | In distribution |
| Implant Kit, 18mm x 22mm x 24mm, 6mm Offset | 18mm x 22mm x 24mm, 6mm Offset | 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.