LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974538

    Validate with FDA (Live)

    Device Name
    MENISCAL REPAIR DEVICE
    Manufacturer
    LINVATEC CORP.
    Date Cleared
    1998-03-03

    (90 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K960940,K955768
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus. Implantation of the device is accomplished through arthroscopy or arthrotomy.

    Device Description

    The Meniscal Repair Device is a cannulated, sterile, single-use bone screw made of an absorbable homopolymer derived from Poly (L-lactic Acid) similar to that used in bioabsorbable suture and will gradually be absorbed into the body.

    AI/ML Overview

    The provided document is a 510(k) summary for a Meniscal Repair Device (Bone Screw) and details its substantial equivalence to predicate devices. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/machine learning performance.

    The study referenced is a non-clinical comparative pull-out strength test, which is a biomechanical test for a physical device, not an evaluation of an AI or algorithmic device.

    Therefore, I cannot extract the requested information (points 1-9) as it pertains to AI/machine learning acceptance criteria and studies from this document. The document describes a traditional medical device (a bone screw) and its safety and effectiveness in comparison to existing devices.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1