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510(k) Data Aggregation

    K Number
    K180960
    Device Name
    FIXIT / ComposiTCP Threaded Anchor System
    Manufacturer
    S.B.M. SAS Sciences for Bio Materials
    Date Cleared
    2018-07-25

    (104 days)

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

    S.B.M. SAS Sciences for Bio Materials

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FIXIT®/ ComposiTCP™ 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; SLAP Lesion 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; Ulnar or Radial Collateral Ligament Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis Repair.
    Device Description
    FIXIT® / ComposiTCP™ Threaded Anchor System is composed of a bioabsorbable composite anchor (30% β-TCP/ 70%PLDL) pre-loaded on a disposable screwdriver and 2 sutures. Different variations of the product are available depending on the type of suture combination (2 flat sutures, or 1 round + 1 flat) For each configuration, the implant is supplied sterile, ready to use.
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