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    K Number
    K202858
    Device Name
    Flex-ThreadTM Distal Fibula Intramedullary Nail System
    Manufacturer
    Conventus Orthopaedics, LLC
    Date Cleared
    2021-01-22

    (116 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K172943
    Why did this record match?
    Device Name :

    Flex-ThreadTM Distal Fibula Intramedullary Nail System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Flex-Thread™ Distal Fibula Intramedullary Nail System is intended for use in the fixation of fibula fractures and osteotomies.

    Device Description

    The Flex-Thread™ Distal Fibula Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the proximal portion of a fibula and cortical screws to further enhance stability and fixation of the fibula.

    AI/ML Overview

    The provided text describes a medical device, the "Flex-Thread™ Distal Fibula Intramedullary Nail System," and its 510(k) submission for FDA clearance. However, the document does not contain information related to software or AI performance.

    Therefore, I cannot extract acceptance criteria or study details regarding device performance from the provided text in the context of an AI/Software device. The submission focuses on the mechanical and functional equivalence of the intramedullary nail system to a previously cleared predicate device.

    Specifically, the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section on page 4 details mechanical testing and a cadaver lab simulation, which are relevant to the physical device's characteristics and use, not software performance.

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