Medtronic Receives FDA Clearance for Stealth AXiS Integrated Spine Surgery System

Medtronic announced U.S. Food and Drug Administration clearance of the Stealth AXiS surgical system, a next-generation platform that brings planning, navigation, and robotics together into a single, intelligent system for spine surgery. The announcement was made on February 13, 2026, from the company's headquarters in Galway, Ireland.

The Stealth AXiS system is cleared for spine procedures in the United States, with an underlying architecture designed to support future cranial and ENT applications, pending 510(k) clearance. Built to support a wide range of surgeon preferences, clinical complexity, and care settings, the platform is designed for use across hospitals and ambulatory surgery centers without relying on multiple standalone technologies.

Grounded in more than 50 years of Medtronic leadership in surgical navigation and robotics, the Stealth AXiS system creates a clear pathway for adoption by combining familiar navigation workflows with a modular robotic design, allowing institutions to deploy what they need today and expand over time as clinical needs evolve.

A key innovation of the Stealth AXiS system is LiveAlign segmental tracking, an industry-first capability that allows surgeons to visualize anatomic motion, surgical adjustments, and patient alignment in real time during spine surgery, without the need for repeated imaging. This capability helps reduce reliance on manual steps and workflow disruption, supporting more consistent execution of patient-specific surgical plans.

A division chief of spine surgery and spine medical director stated that 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 them more consistently achieve their surgical plan without interrupting workflow.

As a cornerstone of Medtronic's AiBLE smart ecosystem, the Stealth AXiS system enables a more intuitive and seamless flow of information across the surgical continuum. By natively integrating planning, navigation, and execution within a single platform, the Stealth AXiS system helps streamline workflows and supports the exchange of insights before, during, and after spine surgery, allowing the broader AiBLE ecosystem to connect devices, software, and data in a more meaningful way.

The senior vice president and president of Medtronic Cranial & Spinal Technologies stated that spine surgery is complex, and variability remains a real challenge. 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.

The modular design enables facilities to scale the system as needed, offering flexibility and adaptability to evolving clinical needs. The Stealth AXiS surgical system reflects Medtronic's focus on building durable platforms that simplify surgical workflows today while enabling future expansion across procedures, specialties, and care settings.

Medtronic Cranial and Spinal Technologies serves over 4 million patients annually with a portfolio of 150 products covering more than 20 pathologies. Medtronic plc is headquartered in Galway, Ireland, and employs a global team of 95,000+ people across more than 150 countries.