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510(k) Data Aggregation

    K Number
    K181640
    Device Name
    X-BOLT Hip Fracture Fixation System
    Date Cleared
    2018-10-12

    (113 days)

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

    X-Bolt Orthopaedics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The X-BOLT® IM Hip Nailing System is intended for use in fracture fixation in adults with osteopenia or osteoporosis. The X-BOLT® IM Hip 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 The X-BOLT® Dynamic Hip Plating System is intended for use in fracture fixation in the proximal femur in adults with osteopenia or osteoporosis. The X-BOLT® Dynamic Hip Plating System is indicated for use in: - · Intracapsular and extracapsular fractures of the femoral neck - · Trochanteric fractures of the proximal femur - · Stable subtrochanteric fractures of the proximal femur
    Device Description
    The X-BOLT® Hip Fracture Fixation System is a single use device intended for long-term (greater than 30 days) implantation into the femur or proximal femur. The system consists of two parts: the IM Hip Nailing System and the Dynamic Hip Plating System. IM Hip Nailing System components: A. X-BOLT®: An expanding hip bolt. B. X-BOLT® IM Hip Nail: A metal nail used with the X-BOLT® for femur fracture fixation. C. End-Cap: Prevents bone ingrowth into the proximal end of the nail. D. Set Screw: Prevents X-BOLT® rotation while allowing dynamic movement. E. X-BOLT® Distal Locking Screws: Bone fixation screws used with the IM Hip Nail for distal fixation. Dynamic Hip Plating System components: A. X-BOLT®: An expanding hip bolt. B. X-BOLT® Dynamic Hip Plate: An angled metal plate used with the X-BOLT® for proximal femur fracture fixation. C. X-BOLT® Cortical Screws: Bone fixation screws used with the Dynamic Hip Plate for proximal femur fracture fixation.
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