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510(k) Data Aggregation

    K Number
    K971358
    Device Name
    BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM
    Manufacturer
    ARTHREX, INC.
    Date Cleared
    1997-07-09

    (89 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K062770,K100936
    Why did this record match?
    Device Name :

    BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM

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

    To provide interference fixation of bone-tendon-bone and soft tissue-grafts in ACL reconstruction through arthroscopy or arthrotorry.

    Device Description

    The Arthrex Bio-Interference Screw is a bioabsorbable interference screw used to fix a graft to a bone in ACL reconstruction. It is inserted between the tunnel wall and graft to hold the graft in place. It is implanted with accessories such as a screw sheath, driver, guide wire, dilator, notcher, tap, and remover.

    AI/ML Overview

    This 510(k) summary (K971358) for the Arthrex Bio-Interference Screw does not contain any information about acceptance criteria or a study proving that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information. The document details the device's functionality, technological characteristics, and intended use, comparing it to a previously cleared Bio-Interference Screw from Arthrex and Linvatec's BioScrew, to argue that it raises no new issues of safety or effectiveness. There is no mention of clinical studies, performance metrics, sample sizes, expert involvement, or ground truth establishment.

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