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510(k) Data Aggregation

    K Number
    K081244
    Device Name
    LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS
    Manufacturer
    BIOMET TRAUMA
    Date Cleared
    2008-07-30

    (90 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K021031,K010437,K000083,K991941,K040833,K033635,K020141,K014194,K011711,K993886,K031093,K953406,K030372,K024248,K021695,K001358,K052037,K050048,K040935,K031919,K024129,K023399,K023324,K022319,K021091,K014276,K013540,K013378,K012024,K011697,K000319,K970290,K961433,K951357
    Why did this record match?
    Reference Devices :

    K021031,K010437,K000083,K991941,K040833,K033635,K020141,K014194,K011711,K993886,K031093,K953406,K030372

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

    Unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amendable to treatment by use of the external fixation modality. For the XFIX® DFS® Rail System the indications are unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, acute or gradual correction and other bone conditions amendable to treatment by use of the external fixation modality.

    Device Description

    The Systems consist of external fixation components and implantable bone screws. The system is utilized in the following manner: bone screws are inserted through the patients skin and soft tissue into bone. The fixator frame of the system is attached the shanks of the bone screws.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (Lower Extremity External Fixation) and the associated FDA clearance letter. It explicitly states that no clinical testing was performed as a basis for substantial equivalence.

    Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be found in this document. The device's clearance was based on its similarity to legally marketed predicate devices, and non-clinical laboratory testing.

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