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510(k) Data Aggregation

    K Number
    K073149
    Device Name
    MENISCAL CINCH
    Manufacturer
    ARTHREX, INC.
    Date Cleared
    2008-02-11

    (95 days)

    Product Code
    GAT,MBI
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K072322
    Why did this record match?
    Device Name :

    MENISCAL CINCH

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

    The Arthrex Meniscal Cinch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.

    Device Description

    The Arthrex Meniscal Cinch is an implantable suture retention device consisting of FiberWire suture and small PEEK tubes. The FiberWire suture is offered in a #2-0 size.

    AI/ML Overview

    The provided text describes a medical device, the Arthrex Meniscal Cinch, and its 510(k) summary for substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

    The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device (K072322, Smith & Nephew ULTRA FAST-FIX & ULTRA FAST-FIX AB Meniscal Repair Systems) based on common functionality and intended use. It states: "Testing of the Arthrex Meniscal Cinch compared to that of the predicate K072322 FAST-Fix support the common functionality and intended use as well as substantial equivalence of the device."

    The document explicitly states: "Minor differences between the Arthrex Meniscal Cinch and the predicate device do not raise any questions concerning safety and effectiveness and has no apparent effect on the performance, function, or intended use of this device."

    Therefore, based on the provided text, I cannot complete the table or answer the specific questions regarding acceptance criteria and a study proving their fulfillment as this information is not present. The document focuses on regulatory approval through substantial equivalence, not detailed performance studies or predefined acceptance criteria.

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