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FDA 510(k)

MotoCLIP/HiMAX Step Staple Implant System

K-Number: K181866 · 2018-08-09

ApplicantCrossroads Extremity Systems, LLC
Decision Date2018-08-09
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MotoCLIP/HiMAX Step Staple Implant System is a medical device manufactured by Crossroads Extremity Systems, LLC. It received FDA 510(k) clearance on 2018-08-09 under approval number K181866. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MotoCLIP/HiMAX Step Staple Implant System?

MotoCLIP/HiMAX Step Staple Implant System is a medical device that received FDA 510(k) clearance on 2018-08-09. It is manufactured by Crossroads Extremity Systems, LLC. The 510(k) number is K181866.

When was MotoCLIP/HiMAX Step Staple Implant System approved by the FDA?

MotoCLIP/HiMAX Step Staple Implant System received FDA 510(k) clearance on 2018-08-09, under approval number K181866.

What company makes MotoCLIP/HiMAX Step Staple Implant System?

MotoCLIP/HiMAX Step Staple Implant System is manufactured by Crossroads Extremity Systems, LLC.

What is the FDA product code for MotoCLIP/HiMAX Step Staple Implant System?

The FDA product code for MotoCLIP/HiMAX Step Staple Implant System is JDR.

Related Clinical Trials

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Crossroads Extremity Systems, LLC

K160118STROPP (Single Tunnel Repair of Plantar Plate) K160300MotoBand(TM) CP Implant System K181410MotoCLIP/HiMAX Implant System K173710MotoBAND CP Implant System K190658MIS Bunion Plating System K181872MIS Bunion System

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Related Devices (Code: JDR)

K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC K160813EasyStepStryker GmbH K153622First Ray Internal Bone Staple SystemFirst Ray, LLC K153770OS2(R)-VP Varisation StapleIn2bones Sas K153395OS2-C Compression StapleIn2bones Sas K153129dynaMX Tabbed StapleMx Orthopedics, Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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