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510(k) Data Aggregation

    K Number
    K152306
    Device Name
    MotoBand¿ CP Implant System
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS, LLC
    Date Cleared
    2015-12-11

    (119 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K083447,K131657,K123562
    Predicate For
    K160300,K173710
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MotoBand™ CP Implant System is indication and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes.

    Device Description

    The MotoBAND™ CP Implant System is comprised of implant plates, bone screws and instruments, having various features and sizes to accommodate differing patient anatomy. Plate geometries include the double Y plate, Y-plate, straight plate (2 hole, 4 hole and 5 hole) and MTP plate with 10° Valgus, 0° Dorsi-Flexion.

    AI/ML Overview

    This document describes the MotoBAND™ CP Implant System, a medical device for orthopedic fixation. It does not contain information about an AI/machine learning device or a corresponding study with acceptance criteria for such a device. The content focuses on the substantial equivalence of the implant system to predicate devices based on theoretical performance analysis.

    Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance for an AI/machine learning device as the provided document pertains to a traditional medical implant, not an AI system.

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