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510(k) Data Aggregation

    K Number
    K233025
    Device Name
    Revolution External Plating System
    Manufacturer
    New Standard Device dba Metalogix
    Date Cleared
    2024-05-30

    (251 days)

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

    New Standard Device dba Metalogix

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Revolution External Plating System is indicated for treatment of a variety of broken or deformed bones: - Stabilizes open and/or unstable fracture of complex proximal and/or distal tibial fractures - Fusions of the joints and bone (hand, foot, long-bone) - Correction of bone or soft tissue deformities - Correction of segmental or non-segmental bone, soft tissue defects or bone loss - Neutralization of fractures stabilized with limited internal fixation - Adult and Pediatric subgroups except newborns
    Device Description
    The Revolution External Plating System is an external open ring fixation system to provide stability for long bone fractures, limb lengthening, and correction of bone deformities all at a distance from the operative focus. When used with other components, this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.
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    K Number
    K181630
    Device Name
    Revolution External Plating System
    Manufacturer
    New Standard Device DBA Metalogix
    Date Cleared
    2019-05-29

    (343 days)

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

    New Standard Device DBA Metalogix

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Revolution External Plating System is indicated for treatment of a variety of broken or deformed bones: - · Stabilizes open and/or unstable fracture of complex proximal and/or distal tibial fractures - · Fusions of the joints and bone (hand, foot, long-bone) - · Correction of bone or soft tissue deformities - · Correction of segmental or non-segmental bone, soft tissue defects or bone loss - · Neutralization of fractures stabilized with limited internal fixation - · Adult and Pediatric subgroups except newborns
    Device Description
    Revolution is an external open ring fixation system to provide stability for long bone fractures, limb lengthening, and correction of bone deformities all at a distance from the operative focus. When used with other components this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone. A plating system consists of a stacked welded plate module and a footplate. These two plates are connected by four super-struts attached by the surgeon to give the best support for the patient. Once assembled, the module is attached to the patient's limb with half-pins or wires. The halfpins are threaded pins with a buttress thread form. Half pins come in three sizes, 4mm, 5mm, and 6mm. Half pins comes in 215mm overall length, but various thread lengths to encompass the size of the bone. Wires come In 1.8mm in diameter and come in 400mm overall lengths. They're meant for traction to the bone. These are inserted through or to the bone and attached to the frame to create a stable construction patient's limb thereby allowing the surgeon to correct or repair the patient's indications.
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