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510(k) Data Aggregation

    K Number
    K252555
    Date Cleared
    2025-11-25

    (104 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medusa Orthopedics Boa External Fixation System and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects.

    The Medusa Orthopedics Boa External Fixation System is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.

    Device Description

    The Medusa Orthopedics Boa External Fixation System is a ring fixator device used to stabilize and maintain alignment of complicated bone fractures, soft tissue and/or congenital deformity repairs of an extremity. The fixator consists of two rings connected by four (4) struts that are lengthened and shortened independently. It is a modular system and facilitates a multitude of frame configurations to provide a wide variety of patient needs. The independent motion of the struts allows the surgeon to adjust the position of the proximal and distal rings. By utilizing the body's natural ability of osteogenesis to grow new bone tissue, the system guides the orientation and position of the new bone to the desired corrected location in a steady controlled manner.

    AI/ML Overview

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