The U.S. Food & Drug Administration (FDA) has granted 510(k) clearance for a software update to a robotic navigation system for spinal surgery, broadening the device’s compatibility with 3D imaging systems.
Robotic Navigation Spine Surgery Software Gets 510(k) Clearance
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Per the 510(k) summary, the robotic navigation system is intended for use “as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan.”
Additionally, the system is indicated for “assisting the surgeon in placing pedicle screws in vertebrae in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the patient in the prone position and is compatible with the Accelus LineSider® Spinal System.”
The device is the REMI™ Robotic Navigation System. The predicate device is the Practical Navigation Surgical Guidance System which is the Remi Surgical Guidance System.
The new clearance means that the REMI Robotic Navigation System can be used with most major 3D imaging systems. According to the press release, the software update “allows image capture with the GE OEC 3D, Ziehm Vision RFD 3D, and Stryker Airo TruCT systems.”
Accelus Chief Executive Officer and Co-Founder Chris Walsh commented, “Cost, footprint and complexity were previously unscalable barriers that kept robotic spine surgery from being performed anywhere but at large hospitals; however, the Remi system’s new clearance provides smaller facilities and ambulatory surgery centers (ASCs) with access to its disruptive technology that can help precisely navigate for accurate screw placement with reduced reliance on traditional fluoroscopy.”
Walsh continued, “We are proud to have achieved this next step as we look to fulfilling the remaining unmet needs in spinal robotic navigation and are excited to now be able to offer our Remi Robotic Navigation System to so many more facilities and surgeons.”
Fusion Robotics, LLC submitted the application and Accelus made the announcement. In 2021, Integrity Implants and Fusion Robotics combined to create Accelus, a medical technology company focused on minimally invasive spine surgery technology.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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