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510(k) Data Aggregation

    K Number
    K232340
    Device Name
    Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor
    Manufacturer
    Arthrex Inc.
    Date Cleared
    2023-09-01

    (28 days)

    Product Code
    MBI,GAT,HWC
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K151092,K120155
    Why did this record match?
    Device Name :

    Arthrex 2.4mm Knotless Hip SutureTak**®** Suture Anchor

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

    The Arthrex 2.4 mm Knotless Hip SutureTak® Suture Anchor is intended to be used for suture (soft tissue) fixation to bone in the hip. Specifically, acetabular labral repair.

    Device Description

    The Arthrex Knotless Hip SutureTak® Suture Anchor is a non-absorbable, “tap-in" suture anchor with a barbed profile and a proximally placed external suture eyelet. The anchors are preloaded with Arthrex Suture and are offered preassembled on an inserter. The device is single-use.

    AI/ML Overview

    This document describes the 510(k) premarket notification for the "Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor". It is not an AI/ML medical device, but rather a surgical implant.

    Therefore, the requested information (acceptance criteria for an AI/ML device, details of an AI/ML study, sample sizes, expert qualifications, etc.) is not applicable to this document.

    The "Performance Data" section in the document refers to mechanical strength testing and bacterial endotoxin testing for a physical medical device, not the performance of an AI/ML algorithm.

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