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510(k) Data Aggregation

    K Number
    K250095
    Manufacturer
    Date Cleared
    2025-09-05

    (234 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 SutureTech All-Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip 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 Repair.

    Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-Foot Reconstruction, Metatarsal Ligament Repair, Digital Tendon Transfers.

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

    Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Repairs.

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

    Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair.

    Device Description

    The All-Suture Dual Anchor System is intended to fixate soft tissue to bone. The device consists of an implant and a set of single use instruments. The implant is available in two configurations to accommodate varying clinical needs: the implant may be used knotted or knotless. The implant and single use instruments are provided ethylene oxide (EO) sterilized and packaged together.

    AI/ML Overview

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