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510(k) Data Aggregation

    K Number
    K140649
    Device Name
    VECTRIX EXTERNAL FIXATOR
    Date Cleared
    2014-12-29

    (291 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Product Code :

    NDK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vectrix External Fixator is indicated for use in which external fixation is necessary for the treatment of long- and shortbone trauma and reconstruction in adult and pediatic patients, including limb lengthening, pseudarthroses, infected fractures, distraction, arthrodesis, and severe open fractures.
    Device Description
    The Vectrix External Fixator is a comprehensive and modular external fixator, the design of which is based on a ball collet pin clamp system and consists of: - 6AL-4V titanium and/or 304SS stainless steel spline . rod (0.125, 0.25, and 0.375 inches in diameter) - . 6AL-4V titanium and/or 316L stainless steel selftapping, threaded fixation pins (5.0 mm and 4.0 mm thread diameter pins with thread lengths from 25 mm to 75 mm, varying in 5 mm increments; and 3.5 mm thread diameter pins with thread lengths of 15 mm) - Titanium pin clamps - Titanium ball collets ● - Titanium collet caps - Titanium drive knob ● - Titanium drive screw ● Fixation pins are percutaneously inserted into the bone segments and secured with pin clamps to the external spline rod. The choice of thread diameter and length is made by the surgeon on a case-by-case basis. The ball and collet design allows extensive pin rotation and, thus, pin placement freedom. The system can be assembled in three sizes, determined by the spline rod size. Furthermore, elements of the system may be combined in a wide range of configurations as needed to achieve the external fixation structure best suited for each patient. The drive screw and drive knob can also be added to the spline rod constructs of each size to mediate bone compression and distraction for limb reconstruction.
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    K Number
    K122208
    Device Name
    EXTERNAL FIXATOR SYSTEM
    Date Cleared
    2012-12-20

    (148 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Product Code :

    NDK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The external fixation system is a device intended to be used in treatment of bone conditions including limb lengthening, osteotomies, the arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
    Device Description
    The external fixation system includes various size components to accommodate various anatomies and injuries. The clamps enable the frame to be coupled to bone by securing the rods and Schanz Screws for the intended use. Components designed for this system are the medium clamp to accept the 8.0mm carbon fiber rod (100mm to 500mm length) and Schanz Screws (4.0mm diameter x 125mm length and 5.0mm diameter x 150mm to 200mm lengths), and the large clamp to accept the 11.0mm carbon fiber rod (100mm to 500mm length) and Schanz Screws (4.0mm diameter x 125mm length, 5.0mm diameter x 150mm length to 200mm lengths, and 6.0mm diameter x 225mm to 300mm lengths).
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    K Number
    K101375
    Device Name
    TRIMED X-FIX
    Manufacturer
    Date Cleared
    2010-09-15

    (121 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Product Code :

    NDK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TriMed X-Fix System is a unilateral external fixation device. It is intended to be used in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
    Device Description
    The X-Fix System is a unilateral external fixation device. It includes various size components to accommodate various anatomies and injuries. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use. The X-Fix System is made of aluminum, black carbon composite and F-138 surgical grade stainless steel.
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