Skip to the latest updates
Clintelo — Innovation IQ for PhysiciansClintelo
My Clintelo
Device IQ
FDA 510(k) clearance · Medtronic · Orthopedics

Stealth AXiS surgical system

FDA clears Medtronic's Stealth AXiS planning, navigation and robotics system for spine surgery.

CompareMedtronic press release
Cleared · 510(k)

Stealth AXiS surgical system

Medtronic · Orthopedics · First integrated planning-navigation-robotics spine platform

Type
Surgical system
FDA route
510(k) clearance
Setting
Hospitals and ambulatory surgery centers
Used by
Spine surgeons
Bottom line for your practice
35s read

Spine surgeons can plan, navigate and use robotic assistance on one platform instead of multiple standalone technologies. The release offers no outcome data showing a patient benefit.

What it is
A platform that brings surgical planning, navigation and robotics together in a single system for spine surgery, with a modular robotic design. Its LiveAlign segmental tracking shows anatomic motion, surgical adjustments and patient alignment in real time.
Indicated for
Patients undergoing spine procedures; the release does not give the full indications for use.
What changes
The release says the platform is designed for use without relying on multiple standalone technologies, and that LiveAlign shows spinal motion in real time without the need for repeated imaging. No study or comparison group is described.
Evidence
Design not reportedStudy not named in the releaseThe release gives no study results.The source does not describe a clinical study or its design. Common for cleared devices, which can rest on equivalence to a predicate.
Watch for
The release contains no clinical data, contraindications or adverse event information. The quoted surgeon is identified as a paid consultant to Medtronic.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
510(k) clearance. Cleared, not approved. The FDA found the device substantially equivalent to one already on the market (its predicate). Clinical trials are often not required.

Clinical summary

Stealth AXiS is a surgical platform that combines planning, navigation and robotics in one system for spine surgery, for use in hospitals and ambulatory surgery centers. Its LiveAlign segmental tracking lets surgeons see anatomic motion and alignment in real time without repeated imaging. The release reports no clinical study data, and at the time of this clearance cranial and ENT uses were still pending.

From the source 7

Medtronic press release

The Medtronic press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. GALWAY, Ireland, Feb. 13, 2026 /PRNewswire/ -- Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced U.S. Food and Drug Administration (FDA) 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.

    Backs · FDA clearance; date 2026-02-13 is the announcement date (the release does not give the FDA decision date)

  2. 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.

    Backs · Pathway 510(k) (the release names 510(k) only when describing the pending cranial and ENT uses); cleared for spine; cranial and ENT pending

  3. Medtronic receives FDA clearance for Stealth AXiS™ surgical system, first integrated planning, navigation and robotics platform for spine surgery

    Backs · 'First' claim: first integrated planning, navigation and robotics platform for spine surgery (release headline)

View all 7 lines

  1. 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.

    Backs · Setting: hospitals and ambulatory surgery centers; no reliance on multiple standalone technologies

  2. 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.

    Backs · LiveAlign real-time tracking without repeated imaging

  3. 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.

    Backs · Modular robotic design

  4. and a paid consultant to Medtronic.

    Backs · Quoted surgeon is a paid consultant

Questions

Ask about Stealth AXiS surgical system. Answers are built from Clintelo's entries and link to each one's source; nothing you type is stored.

Answers come from Clintelo's entries and cite their sources. Not medical advice. Do not include patient information.

Read next

Search all of Device IQ