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510(k) Data Aggregation

    K Number
    K071176
    Device Name
    MODIFICATION TO: ARTHREX INTERFERENCE SCREW
    Manufacturer
    ARTHREX, INC.
    Date Cleared
    2007-08-03

    (98 days)

    Product Code
    MAI,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K062466,K060830,K032717,K051310,K002274
    Why did this record match?
    Device Name :

    MODIFICATION TO: ARTHREX INTERFERENCE SCREW

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

    The Arthrex Biocomposite Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically;

    • Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
    • Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
    • Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Knee: Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
    • Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction
    • Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist
    Device Description

    The Arthrex Biocomposite Interference Screws are intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone.

    AI/ML Overview

    This document is a 510(k) summary for the Arthrex Biocomposite Interference Screw. It describes the device's intended use and claims substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

    Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory submission for premarket notification, not a study report detailing performance metrics against specific acceptance criteria.

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