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510(k) Data Aggregation

    K Number
    K253472

    Validate with FDA (Live)

    Device Name
    FIREFLY® Pedicle Screw Navigation Guide
    Manufacturer
    Mighty Oak Medical
    Date Cleared
    2026-02-25

    (138 days)

    Product Code
    PQC
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K143222,K162419,K181399
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (T1-S2/S2AI and ilium) intended for fusion, with the additional conditions listed below:
    • Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)
    • Pedicle screw's major and minor thread diameters are centered about the longitudinal axis
    • Pedicle screw's longitudinal axis matches the direction of insertion
    • Pedicle screw is intended to be inserted into a pilot hole
    • Pedicle screw's diameter is larger than the pilot hole created with FIREFLY®
    • Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on preoperative scan
    • Compatible pedicle screw spinal system instruments may be used with the FIREFLY® Pedicle Screw Navigation Guide

    • Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity
    • Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be guided to tap pilot holes
    • All other pedicle screw spinal system components and accessories (including non-guided taps) are to be used, after removal of the FIREFLY® Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use

    This device is intended for single use only.

    Device Description

    The FIREFLY® Pedicle Screw Navigation Guide is intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components.

    The FIREFLY® Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging or MRI-Derived Synthetic CT data. Patient-Specific Bone Models may also be provided.

    AI/ML Overview

    N/A

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