Ruthless Spine Earns FDA OK for NavJam Jamshidi Device

Ruthless Spine has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NavJam Jamshidi device, a new spinal instrument for screw placement.

NavJam offers hospitals a practical alternative to bulky, capital-intensive traditional navigation systems, according to the company. It’s designed to work in conjunction with the company’s de novo cleared RJB intraoperative angle measurement instrument.

When combined, the two tools can help to minimize radiation and maintain precision while lowering time and cost, a pressing issue in spine surgery.

Traditional spinal navigation systems (TNS) such as O-arm and CT-based towers improved accuracy compared to freehand techniques, but hospitals often spend $1-3 million to acquire TNS platforms, with additional costs for maintenance, software updates, and specialized training. Registration can add 30 minutes or more to surgical time, exposing patients and staff to radiation while delaying workflow.

The RJB, FDA-cleared in 2023, provided a single-use, Bluetooth-connected module that pairs with a computer tablet to show instrument orientation in real-time. The RJB, according to Ruthless Spine, cut average surgical time by 77 minutes per case and matched TNS accuracy standards by eliminating capital equipment, service contracts, and long setup times.

NavJam augments this concept into the Jamshidi needle step of lumbosacral pedicle screw placement. It’s disposable, pairs wirelessly with a tablet, and offers surgeons real-time trajectory feedback.

“Traditional navigation systems have become too large, too expensive, and too dependent on specialized staff,” said Dr. William Hunter of Duke University. “NavJam and the RJB cut through that noise. They allow us to maintain accuracy while keeping our focus on the patient rather than the equipment.”

Because the platform doesn’t need capital investment or specialized staff, it’s suited for healthcare environments where multi-million-dollar navigation isn’t a viable option. In addition to the United States, NavJam and the RJB are already being used in Turkey, Ukraine, and Africa.

“Spinal surgery is not limited to well-funded centers in the United States and Europe,” said Karlton Spindle of Ruthless Spine. “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.”