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    K Number
    K041356
    Device Name
    ARTHREX TENODESIS SCREW FAMILY
    Manufacturer
    ARTHREX, INC.
    Date Cleared
    2004-11-04

    (168 days)

    Product Code
    HWC,MAI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ARTHREX TENODESIS SCREW FAMILY

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

    The Arthrex Tenodesis Family of Screws, made up of titanium or polylactide (PLLA), are intended to provide soft tissue reattachment, i.e., fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. Specifically:

    Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

    Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction.

    Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis.

    Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

    Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair,

    Device Description

    The Arthrex Tenodesis Family of screws are manufactured using poly(L-lactide) or titanium The Anniox Tonedbel , fully cannulated anchors with a rounded head. The Tenodesis Screws are available with specific instrumentation to alde implantation.

    AI/ML Overview

    This submission describes a medical device, the Arthrex Tenodesis Screw Family, and its intended use. It does not contain information about acceptance criteria or a study that proves the device meets those criteria. Such information would typically include performance metrics, study design, statistical analysis, and a comparison against predetermined thresholds for safety and effectiveness.

    The document provided is a 510(k) summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.

    Therefore, I cannot provide the requested information based on the given input.

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