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510(k) Data Aggregation

    K Number
    K162429
    Device Name
    ZipE Knotless Tissue Repair and Attachment Devices
    Manufacturer
    ZIPTEK, LLC
    Date Cleared
    2017-03-13

    (195 days)

    Product Code
    MAI, KGS, MBI
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZIPTEK, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZIPE® Knotless Tissue Repair and Attachment Devices are intended for fixation of tissue to bone and tissue to tissue. This product is intended for the following indications: - Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-● Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction - . Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair - . Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair - . Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Collateral Ligament Reconstruction - Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction
    Device Description
    The ZipE® Knotless Tissue Repair and Attachment Devices are implantable soft tissue fixation and suture retention devices comprising of a resorbable pledge('button disc ("suture capture"), a titanium screw or biocomposite bone anchor ("plug"), an ultra-high polyethylene (UHMWPE) braided #2 suture having pre-tied half hitched protuberances along its length, a nitinol wire capture holder and a nitinol wire suture shuttle. All components are preloaded onto a stainless steel insertion driver having a TPE tip protector and a silicone O-ring encircling the diameter of the handle to hold the system in place. The implantable elements of the system are the bone anchor, suture and capture; the other components are part of the driver insertion system. The capture is designed to interact with the knotted suture by locking with the protuberances on the suture so that once advanced across the protuberance, it cannot move backward. Once the anchor is inserted into the bone, the pushed down with the stainless steel driver, traveling forward over the knotted suture, preventing movement in the reverse direction, and thereby locking the repair tissue to the underlying tissue. The ZipE® Knotless Tissue Repair and Attachment Devices come with all components pre-assembled into the insertion driver and ready to be operated by the user. Products may be sold separately.
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