Ruthless Spine wins FDA clearance, patent approval for spinal navigation device

Ruthless Spine wins FDA Clearance for its spinal navigation device: ©Endostock - stock.adobe.com

Ruthless Spine said it has received U.S. Food and Drug Administration 510(k) clearance for its NavJam Jamshidi device, alongside a newly allowed U.S. patent application, marking a milestone in the company’s effort to reshape spinal screw placement technology.

The NavJam, also covered by a Taiwan patent, is designed to work with Ruthless Spine’s RJB intraoperative angle measurement instrument, which was cleared last year through the FDA’s De Novo pathway. Together, the devices aim to offer hospitals a cost-effective alternative to capital-intensive traditional navigation systems.

Company officials said the devices simplify workflow, reduce surgical time, and cut down on radiation exposure while maintaining accuracy. Traditional navigation platforms such as O-arm or CT-based towers can cost hospitals $1 million to $3 million, require specialized staff, and extend surgical procedures by 30 minutes or more.

“The NavJam and the RJB cut through that noise,” said William Hunter of Duke University. “They allow us to maintain accuracy while keeping our focus on the patient rather than the equipment.”

Both devices are disposable, connect wirelessly to a tablet, and provide real-time trajectory and orientation feedback to surgeons. The NavJam is designed specifically for the Jamshidi needle step in lumbosacral pedicle screw placement.

Because the platform requires no capital investment, Ruthless Spine said it can be deployed in settings where large systems are impractical, including hospitals in Turkey, Ukraine, and Africa. “By keeping the technology simple, portable, and low-cost, we can make accurate screw placement available in regions where large systems could never be deployed,” said Karlton Spindle, a company representative.

With roughly 1.5 million spinal fusions performed annually in the U.S., demand for faster, more affordable navigation tools is growing. The FDA clearance and patent protection underscore Ruthless Spine’s push to broaden adoption of its platform.

Advances in spinal navigation technology

Spinal navigation and guidance technology is undergoing a wave of innovation as hospitals seek ways to balance precision with efficiency and cost control. Traditional navigation systems, once considered revolutionary, often require major capital investments, extended setup times, and the support of dedicated staff. While they improved accuracy compared with freehand techniques, they also introduced new challenges such as line-of-sight issues, registration errors, and additional radiation exposure.

Recent advances have centered on simplifying workflows and expanding access to navigation tools beyond major academic medical centers. Disposable and wireless instruments that pair with tablets or other off-the-shelf hardware are making it possible to offer real-time trajectory guidance without the burden of multimillion-dollar platforms. These devices also reduce surgical time, lowering patient exposure to infection risk and anesthesia while improving hospital efficiency through faster case turnover.

Another area of progress is portability. Compact navigation systems can be deployed in smaller hospitals or regions with limited resources, ensuring that accurate screw placement is not limited to high-income countries. This global accessibility is increasingly important as spinal procedures rise worldwide, driven by aging populations and higher rates of degenerative spine conditions.

Validation and regulatory review have also played a central role. Newer technologies have had to demonstrate equivalence to traditional navigation in terms of accuracy and safety, giving surgeons confidence that streamlined systems do not sacrifice outcomes. Clinical studies have shown that next-generation devices can match accuracy standards while shortening procedures by more than an hour on average.

As hospitals face pressure to deliver high-quality care at lower cost, the trend is moving toward systems that combine affordability, speed, and reliability. The newest generation of navigation technologies reflects a broader shift in surgical innovation: moving away from bulky, capital-heavy platforms toward nimble, value-based solutions designed to fit seamlessly into the operating room.