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510(k) Data Aggregation

    K Number
    K142643
    Device Name
    Stabilynx PEEK Suture Anchor
    Date Cleared
    2014-12-15

    (89 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    D3 DC, LLC /Stabilynx, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Stabilynx Suture Anchor is a soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as: • Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Capsular Shift/Capsulolabral Reconstruction, Biceps Tendonesis, Deltoid Repair · Knee: Extra Capsular Repairs (Medial Collateral Ligament, Lateral Ligament, Posterior Oblique Ligament), Illiotibial Band Tendonesis, Patellar Tendon Repair · Elbow, Wrist, Hand: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Biceps Tendon Reattachment · Foot and Ankle: Medial Instability Repair/Reconstruction, Lateral Instability Repair/Reconstruction, Achilles Tendon Repair/Reconstruction, Midfoot Reconstruction, Hallux Valgus Reconstruction
    Device Description
    The Stabilynx PEEK Suture Anchor consists of an ethylene oxide sterilized, implantable, poly-ether-etherketone (PEEK) bone screw and ultra high molecular weight polyethylene (UHMWPE) suture anchor is supplied pre-mounted on a disposable Insertion Tool, which consists of a non-patient contact, acrylonitrile butadiene styrene (ABS) handle molded over an externally-communicating, stainless steel shaft. The anchor comes pre-loaded with two (2) high-strength, polyethylene, non-absorbable sutures. The Stabilynx PEEK Suture Anchor design allows a surgeon to create at least one contiguous suture link between one or more adjacent suture anchors after the suture anchors have been inserted into bone. The suture anchor is designed such that one or both of the pre-loaded sutures may be exchanged with one or more sutures connected to an adjacent suture anchor(s).
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