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510(k) Data Aggregation

    K Number
    K253010
    Date Cleared
    2025-10-14

    (25 days)

    Product Code
    Regulation Number
    888.3040
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Mini Superhawk Suture Anchors are intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:

    • Shoulder: Rotator Cuff Repair, 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/Tendon Repair, Bunionectomy, Digital Tendon Transfers.

    • Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.

    • Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

    • Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

    • Hip: Capsular Repair, Acetabular Labral Repair.

    Device Description

    The Mini Superhawk Suture Anchors are anchor devices comprised of polyether ether ketone (PEEK) material that are designed for the fixation of soft tissue to bone. The subject Mini Superhawk system features one 3.75mm diameter Screw-in (start) suture anchor preloaded on an inserter with a 1.5mm suture tape and one knotless 3.75mm diameter Push-in suture anchor preloaded on an inserter with a suture pull tab. The Push-in anchor also includes an auxiliary #0 suture that holds the anchor in place on the inserter until use and is then discarded. The Mini Superhawk Suture Anchors and inserters are assembled as a kit and provided to the end user sterile via ethylene oxide (EO) sterilization.

    AI/ML Overview

    N/A

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