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510(k) Data Aggregation

    K Number
    K200503
    Device Name
    ATL Anchors
    Manufacturer
    International Life Sciences
    Date Cleared
    2020-09-02

    (184 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K193295,K093428
    Why did this record match?
    Device Name :

    ATL Anchors

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

    The ATL Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

    • Shoulder: Rotator Cuff Repair, Acromioclavicular Sepair, Bankart Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.

    • Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Oblique Ligament Repair, Extra Capsular Reconstruction, Illiotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.

    · Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.

    · Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.

    · Hand/Wrist: Scapholunate Ligament Reconstruction, Unar or Radial Collateral Ligament Reconstruction, TFCC.

    · Hip: Acetabular labral repair.

    Device Description

    The ATL Anchors are press fit suture anchors designed to secure the implant in bone and provide suture fixation. There are two configurations: with and without an eyelet. The devices are made from PEEK, are provided sterile, and pre-mounted on a single-use driver. The devices are provided with USP 0 ultra-high molecular weight polyethylene (UHMWPE) suture. ATL Anchors are used with Artelon® provided cannulated or solid stainless-steel drill bits. The devices are tapped into a pilot hole using a standard mallet (not provided).

    AI/ML Overview

    The provided text is a 510(k) summary for the ATL Anchors, a medical device for soft tissue to bone attachment. It details the device description, indications for use, technological characteristics, and summary performance data. However, it does not describe an AI/ML-based device or a study involving human readers or expert consensus for ground truth. Therefore, I cannot generate the requested information about acceptance criteria, performance data, sample sizes, expert involvement, or MRMC studies.

    The document discusses performance tests for the biomechanical properties of the ATL Anchors, such as insertion strength, pull-out strength, and cyclic loading, to demonstrate equivalence to predicate devices. It also mentions sterilization, shelf-life, and biocompatibility testing. These are typical engineering and safety tests for a physical medical device, not performance evaluations of an AI algorithm.

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