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510(k) Data Aggregation

    K Number
    K221621
    Device Name
    Pro-X1™ Trochanteric Nailing System
    Manufacturer
    Date Cleared
    2023-03-06

    (276 days)

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

    X-Bolt Orthopedics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pro-X1™ Trochanteric Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis. The Pro-X1™ Trochanteric Nailing System is indicated for use in: - · Intertrochanteric and subtrochanteric fractures - · Segmental fractures - Comminuted fractures - Pathological fractures - · Fractures with bone loss - · Pseudoarthrosis, non-union, mal-union, and delayed union - · Surgically created defects such as osteotomies
    Device Description
    The Pro-X1" Trochanteric Nailing System is a single use device intended for long-term implantation into the femur. The Pro-X1™ Trochanteric Nailing System consists of the following components: - . Pro-X1™ Expanding Bolt: is a metal expanding hip bolt available in various lengths. - Pro-X1"" Trochanteric Nail: is a metal intramedullary (IM) nail which is designed ● to be used in conjunction with the Pro-X1"" Expanding Bolt to provide fixation of fractures of the femur. It is available in various lengths, in right and left configurations. - Set-Screw: The set-screw prevents the Pro-X1™ Expanding Bolt from rotating, while ● still allowing for dynamic movement. - Interlocking Screws: The interlocking screws are used in conjunction with the Pro-● X1" Trochanteric Nail to achieve distal fixation of the nail. The interlocking screws are available in various lengths.
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