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510(k) Data Aggregation

    K Number
    K072267
    Device Name
    TOTAL HIP SURGETICS NAVIGATION SYSTEM
    Manufacturer
    PRAXIM SA
    Date Cleared
    2007-12-10

    (117 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRAXIM SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TOTAL HIP SURGETICS Navigation System is an optically based surgical navigation system. It is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures. The system is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the pelvis, the femur can be identified by acquiring multiple landmarks. Example procedures include but are not limited to: Hip arthroplasty
    Device Description
    As the equivalent TOTAL KNEE SURGETICS navigation system, the TOTAL HIP SURGETICS navigation system consists of the following major components and subsystems: - The Navigation Station, consisting of a mobile computer system and an . optical localizer - . Ancillary instruments and reflective markers used for reference and registration - . TOTAL HIP SURGETICS software
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    K Number
    K053542
    Device Name
    SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM
    Manufacturer
    PRAXIM SA
    Date Cleared
    2006-04-10

    (111 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRAXIM SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgetics ORTHO OSTEOLOGICS navigation system is an optically based surgical navigation system. It is intended for use as an aid to the surgeon in tracking bone structures and instruments on a 3D model of the patient's bone which is generated through acquiring multiple landmarks. The system is indicated to assist a surgeon to control the lower limb axis during osteotomy procedures. Examples of orthopedic surgical procedures include, but are not limited to: Open wedge osteotomy for the lower limb Closed wedge osteotomy for the lower limb
    Device Description
    The Surgetics ORTHO OSTEOLOGICS Navigation System consists of the following major components and subsystems: - The Surgetics Station, consisting of a mobile computer system and an optical . localizer - Ancillary instruments and reflective markers used for reference and . calibration. - HTO Monitoring Software for, but not limited to open and closed wedge . osteotomy for the lower limb
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    K Number
    K060282
    Device Name
    TOTAL KNEE SURGETICS NAVIGATION SYSTEM
    Manufacturer
    PRAXIM SA
    Date Cleared
    2006-04-10

    (66 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRAXIM SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TOTAL KNEE SURGETICS NAVIGATION SYSTEM is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for : . Total Knee Arthroplasty
    Device Description
    As the equivalent Surgetics ORTHO KNEELOGICS Navigation System, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM consists of the following major components and subsystems: - The Surgetics Station, consisting of a mobile computer system and an . optical localizer - . Ancillary instruments and reflective markers used for reference and registration - TOTAL KNEE SURGETICS software . The main modifications to the predicate device concern the internal architecture of the software, allowing more easily to integrate new implants and to better adapt the workflow to different surgical techniques. New instruments adapted to new implants are also incorporated.
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