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    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
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    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
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    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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    K Number
    K033242
    Device Name
    KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)
    Manufacturer
    IMAGING THERAPEUTICS, INC.
    Date Cleared
    2003-12-31

    (85 days)

    Product Code
    HSH
    Regulation Number
    888.3590
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System (KIMRS) is intended for use in the osteoarthritic knee, where substantial amounts of articular cartilage have degenerated as a result of the disease, and in patients who are candidates for total and/or uni-compartmental arthroplasty procedures. The implant is indicated for the un-cemented treatment of the medial and/or lateral tibial articulating surfaces of the following: Moderate degeneration of the medial or lateral compartment of the knee (grade II-IV chondromalacia) and minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the patellofemoral compartments. The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System is intended to be implanted in the knee as a non-fixated, intra-articular support with minimal to no movement of the device after implantation.
    Device Description
    Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System is a minimally invasive, bone preserving, approach for the treatment of the osteoarthritic knee. Developed from patient Magnetic Resonance (MR) scans a patient specific implant is designed. The treatment allows for the placement of an un-cemented metallic device designed from the patient's natural cartilage and meniscal geometry that is implanted into the joint space either in the medial or lateral compartment above the affected tibial plateau. The femur then articulates against the smooth implant surface. The implant is manufactured from cobalt chromium molybdenum alloy.
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    K Number
    K022779
    Device Name
    OTI UNICONDULAR INTERPOSITIONAL SPACER
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    2002-11-20

    (90 days)

    Product Code
    HSH
    Regulation Number
    888.3590
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    Matched: '888.3590'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OTI Unicondular Interpositional Spacer is intended for use in the Osteoarthritic knee, where substantial amounts of articular cartlige have been lost as a result of the disease. The prostheses will be used in indications for uncemented treatment of the Tibia articulating surfaces (Medial and Lateral) of the following: Moderate degeneration of the Medial and/or Lateral compartment of the knee (grade II-IV chondromalicia ) and minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the patellofemoral components.
    Device Description
    OTI Unicondular Interpositional Spacer System
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