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    K Number
    K252615
    Device Name
    Ruthless Spine RJB
    Manufacturer
    Ruthless, LLC dba Ruthless Spine
    Date Cleared
    2025-09-17

    (29 days)

    Product Code
    QWL
    Regulation Number
    888.4560
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K243375
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ruthless Spine RJB device is intended to measure the angle of surgical instruments in two planes relative to a vertical plumb line in line with gravity. It is indicated for use during lumbosacral pedicle screw implantation in conjunction with applicable spinal instrumentation and as an adjunct to fluoroscopy or intraoperative x-ray. The RJB device is not intended to replace a surgeon's judgment and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.

    Device Description

    The Ruthless Spine RJB device is an intraoperative surgical angle measurement guide that attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The device can measure the axial and sagittal angles relative to gravity. The RJB system only provides measurements for angles in two planes relative to the vertical gravitational plumb line. As such, the RJB device does not provide surgical assistance, guidance, or navigation against patient anatomy. The RJB device is not intended to replace a surgeon's clinical judgement and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.

    The RJB device is provided sterile for single use and utilizes Bluetooth Low Energy (BLE) to connect to a tablet computer and display the angle measurements via the RJB Application (App). A set of handles and instruments compatible with the RJB are provided with the device for use in lumbosacral pedicle screw placement. The following components are part of the RJB system ((R) = Reusable (SU) = Single Use):

    • RJB Device (SU)
    • Quick Connect Axial Ratcheting Handle (R)
    • Straight Probe (R)
    • Duckbill Probe (R)
    • Plastic Ratchet Handle (SU)
    • Plastic Straight Probe (SU)
    • Plastic Duckbill Probe (SU)
    • MPV7 (Jamshidi Needle) Bevel Tip 8 Gauge (SU)
    • MPV7 (Jamshidi Needle) Diamond Tip 8 Gauge (SU)
    • MPV7 (Jamshidi Needle) Bevel Tip 10 Gauge (SU)
    • MPV7 (Jamshidi Needle) Diamond Tip 10 Gauge (SU)
    • RJB Application

    Note, a Tablet Computer is required to operate the device. The Tablet is not provided to the end user.

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