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510(k) Data Aggregation

    K Number
    K003018
    Device Name
    TITAN TIBIAL NAIL
    Manufacturer
    HOWMEDICA OSTEONICS CORP.
    Date Cleared
    2000-12-15

    (79 days)

    Product Code
    HSB,FOR
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TITAN TIBIAL NAIL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Titan Tibial Locking Nail is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked.

    The Titan Tibial Nail System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:

    • Open and closed tibial fractures .
    • Pseudoarthrosis and correction osteotomy .
    • Pathologic fractures, impending pathologic fractures, and tumor resections .
    • Nonunion and malunion
    Device Description

    The Titan Tibial Locking Nail is a cylindrical tube manufactured from titanium alloy slightly bowed to accommodate the shape of the tibia. Locking screws, compression screws and an end cap are manufactured from titanium alloy and are used with the nails. The Titan Tibial Locking Nail is available in three versions, each differing from the other only in diameter, length and number and orientation of screw holes.

    The design and function of the Titan Tibial Locking Nail is substantially equivalent to that of the predicate devices. Both the subject and predicate systems offer tibial nails in varying lengths, and offer a combination of locking screws, compression screws and end caps, the combination of which varies depending on which system is used.

    AI/ML Overview

    The provided text is a 510(k) summary for the Titan Tibial Nail and a letter from the FDA. It does not contain information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a device performance study. The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, not on proving performance against specific acceptance criteria through a detailed study.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text. The text does not describe an acceptance criteria table, device performance metrics, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training and test sets.

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