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510(k) Data Aggregation

    K Number
    K041601
    Device Name
    SURFIX KNEE OSTEOTOMY SYSTEM
    Manufacturer
    SURFIX TECHNOLOGIES
    Date Cleared
    2004-08-27

    (74 days)

    Product Code
    HRS
    Regulation Number
    888.3030
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    Applicant Name (Manufacturer) :

    SURFIX TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SURFIX® Knee Osteotomy System is intended for open and closed wedge osteotomies of the proximal tibia and the distal femur, treatment of bone and joint deformities, and malalignment caused by injury or disease such as osteoarthritis. The SURFIX® Knee Osteotomy System is indicated for knee osteotomies including high tibial osteotomy and femoral osteotomy in the cases of osteoarthritis of the medial tibiofemoral compartment with genu varum and lateral gonarthrosis on genu valgum. Examples include: - Fixation of opening wedge high tibial osteotomy, - Fixation of fracture of the medial tibial plateau, - Osteoarthritis of the medial tibiofemoral compartment with genu varum, - Fixation of closing wedge high tibial osteotomy, - Fixation of fracture of the lateral tibial plateau, - Distal femoral varus osteotomy, - Lateral gonarthrosis on genu valgum.
    Device Description
    The SURFIX® Knee Osteotomy System consists of seven different Stainless Steel plates with a locking system between the threaded sockets of the plates and the lock screws. There are six plates for the proximal tibia and one plate for the distal femur. Their fixation is provided by Titanium alloy or Stainless Steel SURFIX® screws and lock screws available in two versions: cancellous bone screws diameter 6.5 mm and cortical bone screws diameter 4.5 mm. The SURFIX® system fixation creates a single implant/screw unit fixed into the bone thanks the lock screw.
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