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510(k) Data Aggregation

    K Number
    K072704
    Device Name
    UNICOMPARTMENTAL KNEE
    Manufacturer
    VALPO ORTHOPEDIC TECHNOLOGY, INC.
    Date Cleared
    2008-02-19

    (148 days)

    Product Code
    HRY
    Regulation Number
    888.3530
    Why did this record match?
    Applicant Name (Manufacturer) :

    VALPO ORTHOPEDIC TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unicompartmental Knee is solely indicated for medial compartment replacement of the articulating surface of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty procedures. This device is intended for cemented use only.
    Device Description
    The VOT Uni Knec consists of a femoral and a tibial component. The low profiled prosthesis is designed to be nonconstraining and to allow natural weight distribution and flexion. The anatomically designed femoral component is asymmetrically shaped conforming to the natural knee in the coronal and sagittal planes. The post and keel are designed to provide anteroposterior and mediolateral stability. Cobalt Chrome Alloy is used to fabricate the component which is available in three sizes. The tibial component is manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPe). It incorporates a hemispherical shaped articular surface to replicate the natural knce. The component is nonconstraining and designed to allow natural weight distribution and flexion. Dovetailed channels on the undersurface allow for mechanical lock between the implant and the cement mantle. The thickness of the component under the area of the femoral-tibial articulation helps to improve longevity and to minimize the possibility of its fracture. The dual injection ports, the cement delivery instruments, synnge and adapter facilitate cement application. Nine sizes are available to enhance surgical latitude in preoperative planning. Tibial and femoral instruments and trials are also available to facilitate implantation.
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    K Number
    K062734
    Device Name
    ADJUST-RIGHT FIXATION DEVICES
    Manufacturer
    VALPO ORTHOPEDIC TECHNOLOGY, INC.
    Date Cleared
    2006-11-22

    (70 days)

    Product Code
    JDR, HWC, MBI
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    VALPO ORTHOPEDIC TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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