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510(k) Data Aggregation

    K Number
    K050634
    Device Name
    MODIFICATION TO: ARTHREX V-TAK
    Manufacturer
    ARTHREX, INC.
    Date Cleared
    2005-03-21

    (12 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K022234
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arthrex V-Tak™ is intended to provide fixation of suture to bone in surgeries of the foot, ankle, hand, wrist, and elbow. Specific indications are listed below:

    • Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow. Reconstruction
    • Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
    • Foot: Hallux Valgus reconstruction
    • Ankle: Mid-foot reconstruction
    Device Description

    The Arthrex V-Tak™ is a fully threaded, notched, degradable anchor.

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) K05-0634 for the Arthrex V-Tak™ device does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the format of an AI/ML device study report.

    The document is a traditional 510(k) submission for a medical device (a degradable fastener for suture to bone fixation) and focuses on demonstrating substantial equivalence to a predicate device based on its design, materials, and intended use. It does not involve a study comparing the performance of the device against specific metrics in the way an AI/ML device would.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and study as if it were for an AI/ML device.

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