Medtronic announced that it received FDA clearance for its Stealth AXiS robotic system for spine surgery. Stealth AXiS brings planning, navigation and robotics together into a single, intelligent system. It received clearance for spine procedures in the U.S. and has an underlying architecture designed to support future cranial and ENT applications. Those remain pending further FDA 510(k) clearances.
Related: ZOLL achieves EU MDR approval for Zenix device
Medtronic built its system to support a range of surgeon preferences, clinical complexity and care settings. It designed Stealth AXiS for use across hospitals and the increasingly popular ambulatory surgery centers (ASCs). The system can operate in these settings without relying on multiple standalone technologies.
Stealth AXiS combines familiar navigation workflows with a modular robotic design, the medtech giant says. It allows institutions to deploy what they need and expand over time as needs evolve. The company built the system on its existing Mazor and StealthStation technologies.
This marks the latest surgical robotics win for Medtronic, which picked up its first FDA nod for its Hugo soft tissue robot at the end of 2025. It also sets the company up to compete in the robotic spine surgery space, which currently features orthopedic giants like Zimmer Biomet and its Rosa platform, as well as Stryker and its Mako system.
“Spine surgery is complex, and variability remains a real challenge,” said Michael Carter, SVP and president of Medtronic Cranial & Spinal Technologies. “The Stealth AXiS system is designed to make advanced technology more usable and clinically meaningful, helping surgeons deliver more predictable, personalized care while laying the foundation for continued innovation.”
Medtronic said the LiveAlign sentimental tracking feature represents a key innovation within the Stealth AXiS system. The company labels it an “industry-first capability” that enables surgeons to visualize anatomic motion, surgical adjustments and patient alignment in real time during spine surgery. They can accomplish this without the need for repeated imaging.
According to Medtronic, the feature helps reduce reliance on multiple steps and workflow disruption. It supports more consistent execution of patient-specific surgical plans.
Stealth AXiS also represents a cornerstone of Medtronic’s AiBLE smart ecosystem. AiBLE features innovative navigation, robotic guidance systems, data and AI, imaging, software and implants. These enable more predictable outcomes in spine procedures.
Medtronic said the system enables a more intuitive and seamless flow of information across the surgical continuum. It natively integrates planning, navigation and execution within a single platform to streamline workflows and support the exchange of insights before, during and after surgery.
“The Stealth AXiS system represents a meaningful step forward in how we think about navigation and robotics working together,” said Dr. Ronald A. Lehman, Jr., tenured professor of Orthopaedic Surgery (Neurological Surgery) at Columbia University, division chief of Spine Surgery, and spine medical director at The Spine Hospital at NewYork-Presbyterian/The Allen Hospital, and a paid consultant to Medtronic. “One of the biggest challenges in spine surgery has been understanding and responding to how the spine moves during a procedure. The Stealth AXiS system gives surgeons real-time visibility into that motion, helping us more consistently achieve our surgical plan without interrupting workflow. To me, this is truly game changing technology.”
