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510(k) Data Aggregation

    K Number
    K090786
    Device Name
    KENS INTERNAL FIXATION SYSTEM
    Manufacturer
    KENS FINEMEDTECH SDN. BHD
    Date Cleared
    2009-06-18

    (87 days)

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

    KENS FINEMEDTECH SDN. BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices of KENS INTERNAL FIXATION SYSTEM are provided NON-STERILE. The Bone Plate, Bone Screw is intended for use in fixation of fractures to the various bones, including the clavicle, pelvis, scapula, calcaneus, long bone ( humerus, ulna, radius, femur, tibia, and fibula), an small bone ( metacarplas, metatarsals, and phalanges). The DHS/DCS Plate System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fractures. Pin and Wire are indicated for use in fracture fixation, for healing of comminuted bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.
    Device Description
    The KENS INTERNAL FIXATION SYSTEM consists of NON-STERILE plate, screw, pins, wires and DHS/DCS plate systems. The plates are devices, which are fastened by screws to bone for the purpose of providing fixation. According functional differences, plates are gathered in four kinds: Dynamic Compression Plate (DCP), tubular, special and DHS/DCS. The shape of the plate is designed to an adaptation of the local bone anatomy and doesn't denote any particular function. KENS plates are divided as the following: | Product Name | Geometry Shape | |--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | DCP | Narrow, Broad, Broad Limited, Narrow Limited,<br>Lengthening-Narrow, Lengthening Broad, Straight, | | Tubular | Semi-tubular, one-third, quarter | | Special | T-shaped, T-Buttress, T-Oblique, L-shaped, L-buttress,<br>Cobra Head, Lateral tibial head, Condylar Buttress, Spoon,<br>Reconstruction, Reconstruction-curved, Hook, H-shaped,<br>W-shaped, Cloverleaf, Calcaneal, Y-Calcaneal, Adaptation,<br>Compression, Multiple Fragment Plate, Condylar | | DHS/DCS | Dynamic Hip Screw, Dynamic Condylar Screw | KENS screws & plates are grouped in 3 subsystems: mini fragment, small fragment and basic (also known as large fragment). The size range of plates are in thickness from 1.0 to 6.0mm, width from 3.8 to 17mm, length 17 to 370mm. and hole number from 2 to 22 holes. The size ranges of screw are in thread diameter from 1.5 to 7.0 mm. total length from 6 to 180mm. In which the screws are differentiated in 5 main kinds of: cortex, cancellous, malleolar, shaft and cannulated screws. The DHS/ DCS plate system consists of DHS/DCS Plate, Lag Screw, DHS/DCS Compression Screw and 4.5mm Cortex Screw. The DHS Plates are available with short and standard barrel which length is 25mm and 38mm respectively. And the barrel angles are available in 95°, 135°, 140°, 145° and 150°. The self-tapping 4.5mm Cortex Screw can also be used to fix the DHS/DCS Plate to the femoral shaft. The DHS/DCS Screw is available in total length from 50 to 145 mm, thread length 22mm, shaft diameter 7.9mm, and outer diameter from 12.5 to 14mm. The DHS/DCS Compression Screw with buttress thread, length 26mm and outer diameter 4.0mm, can be used to achieve fracture compression. Pins and wires are divided into groups of: - . Kirschner wires are in length from 100 to 300mm and range in diameter is under 3.0mm and are available with trocar or diamond tip. - Steinmann pin are in diameter 2.0~5.0mm and range in length from 125 to 300mm and are available with trocar or diamond tip. - . Schanz pins are supplied in diameter 1.25 ~6.0 and range in length from 80mm to 300mm. - Knowles pins are with square and hexagonal drive, a break off length ranges from 63.5 to 152.4mm, and a thread diameter 4.0 & 4.8mm.
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