Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971993
    Device Name
    ODI COMPRESSION HIP SCREW SYSTEM
    Date Cleared
    1997-11-12

    (167 days)

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

    ORTHOPAEDIC DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ODi Compression Hip Screw System will be used on indications that are common with presently marketed compression hip screw systems. The primary indications are for fixation/stabilization of intertrochanteric fractures, some high subtrochanteric fractures and intracapsular fractures, provided that weight bearing is not allowed until the fracture shows evidence of union. The device is intended to stabilize fragments of the fracture until bony union can occur.
    Device Description
    The Orthopedic Designs, Inc. Compression Hip Screw System is a cannulated lag and compression screw system to be used with a side plate for fracture fixation and stabilization of the proximal femur until bony union can occur. The system includes a lag screw that may be utilized alone with a side plate, or for compression of a fracture, may be used with a compression screw. Each system shall consist of the same material when used and shall not be mixed. Titanium Alloy and Stainless Steel within the same use. The distal end of the lag screws are keyed, but not threaded, thereby allowing the screw to slide within the barrel of the side plate while preventing rotation of the lag screw within the head of the femur. Immediate compression may be obtained with the use of a compression screw threaded into the inner canal of the lag screw. A compression screw locking mechanism called a jam screw is also available, providing a safe mechanism to lock the compression screw in place. The jam screw will prevent a common natural migration of the compression screw from the lag attachment. The side plates, lag screws, compression screws, cortical bones screws and instruments are similar in design, materials and intended use to other 510(k) cleared devices/instruments which are in commercial distribution. A range of system component sizes and lengths will be made available, offering a range of fracture compression. The components are designed to be manually or mechanically inserted using common (e.g. American Orthopedic) manual and power instrumentation.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1