Ruthless Spine Announces Intellectual Property News and 510(k) Clearance on Revolutionary Spinal Instrument

September 17, 2025 at 20:05 PM EDT

Device is designed to work in tandem with Ruthless Spine's De Novo cleared RJB™ intraoperative angle measurement instrument

Ruthless Spine today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the NavJam™ Jamshidi device, and as of today, U.S. Patent Office records indicate that the status of the NavJam™ Jamshidi patent application is allowed. The NavJam™ Jamshidi device is also covered by an issued Taiwan patent and is designed to work in tandem with Ruthless Spine’s De Novo cleared RJB™ intraoperative angle measurement instrument.

The NavJam marks a significant step forward in spinal screw placement technology, offering hospitals a practical alternative to bulky, capital-intensive traditional navigation systems. By simplifying workflow, reducing surgical time, and eliminating costly infrastructure, the NavJam and RJB together provide a scalable solution to one of the most pressing challenges in modern spine surgery: significantly minimizing radiation and maintaining precision while lowering time and cost.

Traditional spinal navigation systems (TNS) such as O-arm and CT-based towers improved accuracy compared to freehand techniques, but their drawbacks are increasingly clear. 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. Even after setup, TNS remains vulnerable to registration errors and line-of-sight disruptions.

Ruthless Spine’s platform originated from the idea that an alternative to traditional navigation could be possible. The RJB, cleared in 2023 through the FDA De Novo pathway, provided the first proof point: a single-use, Bluetooth-connected module that pairs with a computer tablet to display instrument orientation in real time. By eliminating capital equipment, service contracts, and long setup times, the RJB reduced average surgical time by 77 minutes per case while matching the accuracy standards of TNS.

The NavJam expands this concept into the Jamshidi needle step of lumbosacral pedicle screw placement. Like the RJB, it is disposable, pairs wirelessly with a tablet, and provides surgeons with real-time trajectory feedback. The device functions as a guide, supporting surgical judgment rather than replacing it.

Commenting on the announcement, Dr. William Hunter of Duke University said, “Traditional navigation systems have become too large, too expensive, and too dependent on specialized staff. 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 requires no capital investment or specialized staff, it is particularly suited for healthcare environments where multimillion-dollar navigation is not 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.”

Accuracy remains the cornerstone of spinal screw placement, and Ruthless Spine’s platform was required to demonstrate equivalence to TNS during FDA De Novo review. Validation studies confirmed its reliability, enabling surgeons to achieve precise screw placement without the risks associated with registration errors or prolonged anesthesia time.

Shorter procedures improve patient safety by reducing infection exposure and minimizing anesthesia duration. Faster case turnover also supports hospital efficiency, easing the burden on perioperative teams. With 1.5 million spinal fusions performed annually in the United States, demand for efficient, high-quality navigation instruments and robots is accelerating. Hospitals are under pressure to reduce costs while maintaining outcomes, and Ruthless Spine’s platform offers a practical response.

With its FDA clearance and new Jamshidi U.S. patent, in addition to existing international protections, NavJam underscores Ruthless Spine’s commitment to disruptive, value-based innovation in spinal surgery. By focusing on accessibility, accuracy, and efficiency, the company has reimagined what screw placement can look like in the modern operating room.

About Ruthless Spine

Ruthless Spine is a Los Angeles–based MedTech company dedicated to reducing patient radiation and simplifying spine surgery by eliminating capital equipment expense and training burdens of traditional navigation or robots. Its FDA-cleared RJB™ is a disposable, Bluetooth-connected angle measurement instrument for lumbosacral pedicle screw placement that pairs with standard Android or iOS tablets, providing real-time orientation with a 30-second setup and no specialized staff. The company’s NavJam™ Jamshidi expands this approach to the entry step of screw placement, offering wireless trajectory feedback in a similarly streamlined format. Ruthless Spine holds U.S. and Taiwan patents. Learn more at www.ruthlessspine.com