MotoCLIP/HiMAX Step Staple Implant System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181866 FDA 510(k)
- FDA Product Code
- JDR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MotoCLIP/HiMAX Step Staple Implant System is a Nitinol Superelastic bone staple used in surgery for bone fragment osteotomy fixation and joint arthrodesis in the hand and foot. It is a type of orthopedic implant.
The system is supplied for use in surgical procedures and is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis. The device has been cleared under FDA 510(k) number K181866.
Frequently asked questions
What is the MotoCLIP/HiMAX Step Staple Implant System used for?
The MotoCLIP/HiMAX Step Staple Implant System is used for bone fragment osteotomy fixation and joint arthrodesis in the hand and foot, as it is a type of orthopedic implant designed for surgical procedures.
Is the MotoCLIP/HiMAX Step Staple Implant System supplied sterile?
The description does not explicitly state that the MotoCLIP/HiMAX Step Staple Implant System is supplied sterile, so its sterility should be confirmed with the manufacturer or supplier.
What material is the MotoCLIP/HiMAX Step Staple Implant System made of?
The MotoCLIP/HiMAX Step Staple Implant System is made of Nitinol, which is a superelastic material.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MotoCLIP/HiMAX Step Staple Implant System (K181866) — FDA 510(k ..., CROSSROADS EXTREMITY SYSTEMS 7200-ST08KT MotoCLIP/HiMAX Step Staple, PDF INSTRUCTIONS FOR USE MotoCLIPTM/HiMAXTM Implant System, Staples - MINIBunion™ - CrossRoads Extremity
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181866 | Class II | Active |
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Manufacturer
- Manufacturer
- Crossroads Extremity Systems, LLC
Sources (1)
- FDA 510(k) K181866 24 fields · synced Sep 22, 2026