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510(k) Data Aggregation

    K Number
    K233910
    Device Name
    Vertex Hip Fracture Nailing System
    Manufacturer
    Date Cleared
    2024-04-04

    (114 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    OrthoXel DAC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vertex Hip Fracture Nailing System is intended for temporary fixation of stable and unstable fractures of the proximal femur. The Vertex Nail is indicated for use in adult patients for treatment of: - Pertrochanteric fractures; - · Intertrochanteric fractures; - · High subtrochanteric fractures - · Combinations of the above fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated for use in adult patients for treatment of: - · Pertrochanteric fractures associated with shaft fractures; - · Pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas; - · Impending pathological fractures; - · Long subtrochanteric fractures; - · Ipsilateral femoral fractures; - · Proximal or distal non-unions, malunions, revision procedures and tumor resections.
    Device Description
    The Vertex Hip Fracture Nailing (HFN) System is a cephalomedullary fixation system designed to be implanted and interlocked proximally and distally using bone screws by means of a provided surgical instrumentation kit. Like many of the currently marketed intramedullary nails, the Vertex HFN offers several different proximal and distal locking options from which the surgeon may choose, depending on the nature of the fracture. The Vertex HFN System includes long and short cephalomedullary nails, lag screws, bone screws, and endcaps all of varying lengths and diameters. All parts of the system are manufactured from Titanium 6AL4VELi.
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    K Number
    K181375
    Device Name
    Apex Femoral Nailing System
    Manufacturer
    Date Cleared
    2018-07-17

    (54 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    OrthoXel

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Apex Femoral Nailing system is intended for temporary fixation of the fractures of the femur. The Apex nail is indicated for used in adult patients for treatment of: - Open and closed fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures; - Fractures involving osteopenic or osteoporotic bone; - Fractures with bone loss; - Pseudoarthosis, nonunion, and malunion; - Correction osteotomy; - Pathologic fractures and prophylactic nailing of impending pathologic fractures; - Periprosthetic fractures; - Closed supracondylar fractures (retrograde only) and: - Intertrochanteric and subtrochanteric fractures (antegrade only)
    Device Description
    The Apex Femoral Nailing system is a femoral intramedullary fixation system designed to be implanted and interlocked proximally and distally using bone screws or a provided surgical instrumentation kit. Like many of the currently-marketed intramedullary nails, the Apex Nail offers several different proximal and distal locking options from which the surgeon may choose, depending on the fracture. An insert within the proximal nail stem maintains the high torsional stability of static locking when the construct is locked in a dynamization mode. The Apex Femoral Nailing System include a femoral nail, bone screws, bolts and endcaps of varying sizes. All parts of the system are manufactured from Titanium 6AL4VELi. The Apex Femoral Nail, screw, bolt and endcap are available in varying lengths and diameters.
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    K Number
    K170972
    Device Name
    Apex Tibial Nailing System
    Manufacturer
    Date Cleared
    2017-12-20

    (261 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    OrthoXel

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Apex Tibial Nailing system is intended for temporary fixation of the fractures of the tibia. The Apex nail is indicated for used in adult patients for treatment of: - · Open and closed tibial fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures; - · Fractures involving osteopenic or osteoporotic bone; - · Fractures with bone loss; - Pseudoarthosis, nonunion, and malunion; - · Correction osteotomy; - · Pathologic fractures and prophylactic nailing of impending pathologic fractures; and - · Reconstruction following tumour resection.
    Device Description
    The Apex Tibial Nailing System is a tibial intramedullary fixation system designed to be implanted and interlocked proximally and distally using bone screws by means of a provided reusable surgical instrumentation kit. Like many of the currently-marketed intramedullary nails, the Apex Nail offers several different proximal and distal locking options from which the surgeon may choose, depending on the fracture. An insert within the proximal nail stem maintains the torsional stability of static locking when the construct is locked in a dynamization mode. The Apex Tibial Nailing System includes a tibial nail, bone screws and endcaps of varying sizes. All parts of the system are manufactured from Titanium 6AL4VELi. The Apex Tibial Nail, screw and endcap are available in varying lengths and diameters.
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