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510(k) Data Aggregation

    K Number
    K983339
    Device Name
    OSTEO DYNATROC PROXIMAL FEMORAL NAIL
    Manufacturer
    OSTEONICS CORP.
    Date Cleared
    1998-10-27

    (34 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Osteo DynaTroc™ Proximal Femoral Nail is indicated for proximal femoral fracture fixation, which includes the following:

    • . Intertrochanteric fractures
    • . Pertrochanteric fractures
    • . High subtrochanteric fractures
    Device Description

    The Osteo DynaTroc™ Proximal Femoral Nail is a cylindrical, cannulated titanium alloy tube with three distal slots, which is slightly bowed (4 degrees) in the medial-lateral plane to accommodate the shape of the proximal femur. The Osteo DynaTroc™ Proximal Femoral Nail is available in three different proximal/distal nail diameters to accommodate the differing morphology of small, average, and larger size patients. The distal tip of the nail contains three slots that are intended to reduce bone stresses normally incurred during insertion of the nail and post operative healing. Two locking holes, one round and one oval-shaped, are located toward the distal end of the nail but are superior to the distal slots. The superior end of the nail contains two screw holes to accommodate lag screws. The superior lag screw hole accommodates a 6.5mm diameter lag screw, and the inferior lag screw hole accommodates a 10mm diameter lag screw. All screw holes are oriented in the medial-lateral plane. An end cap (protection screw) is screwed into the proximal end of the nail to prevent excessive tissue ingrowth. The Osteo DynaTroc™ Proximal Femoral Nail is available in lengths of 180mm, 205mm, and 220mm, and in proximal/distal diameters of 17mm/12mm, 16mm/11mm, and 15mm/10mm. The surfaces of the Osteo DynaTroc™ Proximal Femoral Nail and related components are anodized with a Type II coating process.

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification Summary for a medical device called the "Osteo DynaTroc™ Proximal Femoral Nail." This summary focuses on demonstrating substantial equivalence to predicate devices and describes the device's design, intended use, and general regulatory information. It does not contain any information regarding acceptance criteria, study data, sample sizes, ground truth establishment, or expert consensus related to device performance or effectiveness.

    Therefore, I cannot provide the requested information from the text. The document is a regulatory submission for market clearance based on substantial equivalence, not a study report detailing clinical performance or validation against specific acceptance criteria.

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