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510(k) Data Aggregation

    K Number
    K073233
    Device Name
    ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS
    Manufacturer
    ADVANCED BIO-SURFACES, INC.
    Date Cleared
    2008-01-28

    (74 days)

    Product Code
    HSH
    Regulation Number
    888.3590
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED BIO-SURFACES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrthoGlide Lateral Knee Implant is intended for use in the osteoarthritic knee, where substantial amounts of cartilage have been lost as a result of the disease. The device is indicated for uncemented use in the treatment of moderate degeneration of the lateral compartment of the knee (grade II-IV chondromalacia) with no more than minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the medial and patellofemoral compartments in patients with osteoarthritis.
    Device Description
    The OrthoGlide Lateral Knee Implant is placed in the lateral compartment of the knee between the tibial plateau and femoral condyle by means of minimally invasive surgery. The instruments are intended to aid in the surgical preparation of the implant site and implant placement. The OrthoGlide is made of a Cobalt-Chrome-Molybdenum Alloy. Device geometry and ligament tension combine to keep the implant in place. The implant covers the lateral tibial plateau. The device is designed to improve the alignment of the knee, returning the joint to a less valgus position. Realignment of the knee distributes the weight-bearing forces across the joint and helps restore the normal relationships of the articular surfaces and the surrounding capsular, ligamentous and muscular structures. The device is designed to help relieve pain by providing an articulating surface with a low coefficient of friction and high durability. Device geometry improves knee alignment and joint spacing. The device surface is smooth and when wet, is intended to mimic the lubricious surface previously provided by the articular cartilage.
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    K Number
    K053094
    Device Name
    ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056
    Manufacturer
    ADVANCED BIO-SURFACES, INC.
    Date Cleared
    2006-02-06

    (95 days)

    Product Code
    HSH
    Regulation Number
    888.3590
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED BIO-SURFACES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orthoglide Medial Knee Implant is intended for use in the osteoarthritic knee, where substantial amounts of cartilage have been lost as a result of the disease. The device is indicated for uncemented use in the treatment of moderate degeneration of the medial compartment of the knee (grade II-IV chondromalacia) with no more than minimal degencration (grade I-II chondromalacia, no loss of joint space) in the lateral and patellofemoral compartments in patients with ostcoarthritis.
    Device Description
    The Orthoglide Medial Knee Implant is placed in the medial compartment of the knee between the tibial plateau and femoral condyle by means of minimally invasive surgery. The instruments are intended to aid in the surgical preparation of the implant site and implant placement. The Orthoglide is made of a Cobalt-Chrome-Molybdenum Alloy. Device geometry and ligament tension combine to keep the implant in place. The implant covers the tibial plateau. The device is designed to improve the alignment of the knee, returning the joint to a more valgus position. Realignment of the knee distributes the weight-bearing forces across the joint and helps restore the normal relationships of the articular surfaces and the surrounding capsular, ligamentous and muscular structures. The device is designed to help relieve pain by providing an articulating surface with a low coefficient of friction and high durability. Device geometry improves knee alignment and joint spacing. The device surface is smooth and when wet, is intended to mimic the lubricious surface previously provided by the articular cartilage.
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