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510(k) Data Aggregation

    K Number
    K170868
    Device Name
    FIXIT Threaded Anchor System
    Manufacturer
    S.B.M SAS Science for Bio Materials
    Date Cleared
    2017-11-30

    (252 days)

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

    S.B.M SAS Science for Bio Materials

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FIXIT® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures: Shoulder: Rotator Cuff Repair; Bankart Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction; Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Anterior Cruciate Ligament Repair: Medial Collateral Ligament Repair: Lateral Collateral Ligament Repair: Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ; Wrist/Hand: Scapholunate Ligament Reconstruction: Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment: Unar or Radial Collateral Ligament Reconstruction: Temis Elbow Repair and Lateral Epicondylitis Repair
    Device Description
    FIXIT® is a threaded anchor system made of Duosorb® 30 (β-TCP 30%/ PLDLA 70%), a composite, bioabsorbable material. The implant is available in 2 different configurations: - · FIXIT®Knotless: supplied in a holder, - FIXIT®: pre-loaded on a disposable screwdriver with 2 sutures. The implant is supplied sterile, ready to use.
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