A single-surgeon case series using Ruthless Spine’s RJB trajectory guidance system reports no reoperations for screw malposition across 44 lumbar fusion cases and 264 pedicle screws. The study, authored by Shane S. Pak, MD, covers surgeries performed over a 21-month period at three community hospitals, none with more than 300 beds. All patients were treated as inpatients and followed for at least 12 months. Pak reports no takebacks, no revisions for screw malplacement and no neural injuries attributed to a misplaced screw.
The hospital setting is one of the more interesting aspects of the report. Most of the published literature on navigated screw placement comes from large academic centers with intraoperative CT, dedicated navigation hardware and staff trained to run it. Community hospitals often can’t justify that investment. The RJB system takes a different approach: version 6, used in every case in this series, runs on Android tablets and works alongside a conventional fluoroscopic C-arm. Pak used whichever unit was available at the hospital that day, either a Philips Zenition 30 or a GE OEC 9800 Plus.
All screws were placed through an open approach, midline or Wiltse.
Most of the cases were short constructs. Twenty-one patients had single-level primary lumbar fusions (84 screws), 12 had two-level fusions (72 screws) and seven had three-level fusions (56 screws). Two patients underwent eight-level primary fusions, for a combined 36 screws. The series also includes two revision surgeries, one spanning two levels and the other four, accounting for 16 screws between them. Revision cases are generally where screw placement gets harder, with scar tissue and altered anatomy obscuring the usual landmarks, so it’s worth noting they were part of the mix, even if only two.
Pak frames the results within existing research on guided screw placement. He points to an early randomized trial that found pedicle perforation in 4.6% of navigated screws compared with 13.4% of screws placed conventionally. He also cites a 2019 meta-analysis of 51,161 screws, which reported accuracy of 95.5% with CT-based navigation, 93.1% with freehand technique and 91.5% with fluoroscopic guidance. The differences are small in percentage terms but carry more weight in the thoracic and cervical spine, in deformity, in osteoporotic patients and after prior surgery, where there is little room for error.
According to the document, FDA clearance for the RJB system required the company to show accuracy and reproducibility on par with currently marketed traditional spinal navigation systems.
Pak’s conclusion is that the system is safe and effective for pedicle screw placement. The data support that within limits. This is a retrospective review of one surgeon’s cases, with no comparison group. The endpoint is clinical, meaning the absence of reoperations tied to screw position, rather than postoperative CT assessment of breach rates, which is how most accuracy studies are measured. Without CT grading, the results can’t be compared directly with the navigation figures cited in the paper. The series is also limited to open lumbar procedures, so it says nothing yet about thoracic or cervical use, or about minimally invasive surgery.
Still, for surgeons at smaller hospitals, the report is a practical data point. If a tablet-based system working with existing fluoroscopy can deliver results like these, it could make trajectory guidance accessible in places where full navigation platforms remain out of reach. Multi-surgeon studies with imaging-based accuracy data would go a long way toward confirming that.
About Ruthless Spine (NASS 2026. Booth 1031)
Ruthless Spine’s mission is to bring “zen” back to spine surgery by addressing the challenges faced by spinal surgeons, such as the need for significant investments in capital, time, and manpower to achieve accurate outcomes. Ruthless Spine focuses on providing innovative, accurate, and efficient solutions that are easy to use and do not require bulky, complex machinery. For more information please contact: http://www.ruthlessspine.com
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