MedicalSpine surgery robot

Mazor X Stealth Edition

Name: Mazor X Stealth Edition
Brand: Medtronic (originally Mazor Robotics, Israel)

by Medtronic (originally Mazor Robotics, Israel)

Mazor X is a robot arm that guides spine surgeons when they place screws in the spine. The Stealth Edition joins Mazor's robot with Medtronic's surgical navigation software and turns flat X-ray pictures into a 3D image. Fierce Biotech, 30 Jan 2019

Stage 5 of 5

Regulator-cleared or mass market

Which rule placed it

Evidence: Independently reported
Human help: None reported
Last milestone: 13 Feb 2026

01Can I get it?

Yes, in places

Where it works today: In use in hospitals; an FDA recall record from January 2026 lists 549 Mazor X systems in use. FDA recall record, posted 16 Jan 2026
Published price: No published price in our sources.
Human help: A surgeon operates; the robot arm holds tools on the planned path.

02Track record

What has actually happened

Every milestone is dated and links to the page it comes from. Lines marked company-reported rest on the maker's own word.

13 Feb 2026
Update
The FDA cleared Medtronic's newer Stealth AXiS system through the 510(k) route. It puts surgery planning, navigation and robotics in one spine platform.
Becker's Spine Review, 13 Feb 2026Company-reported
10 Dec 2025
Setback
Medtronic started a Class 2 recall of the Mazor X system over software errors that can put surgical tools in the wrong position. The FDA record lists 549 systems.
FDA recall record, posted 16 Jan 2026
Jan 2019
On sale
Medtronic launched the Mazor X Stealth Edition in the US, and it began treating its first US patients.
Fierce Biotech, 30 Jan 2019Company-reported
19 Dec 2018
Funding
Medtronic completed its purchase of Israel-based Mazor Robotics for about $1.7 billion. Medtronic had already bought a 10.6% stake in stages.
MassDevice, 19 Dec 2018
19 Dec 2018
Update
Before the Stealth Edition, Mazor already sold the Mazor X guidance system and an older spine robot called Renaissance.
MassDevice, 19 Dec 2018
Nov 2018
Cleared · sets the stage
The FDA cleared the Mazor X Stealth Edition through the 510(k) route.
Fierce Biotech, 30 Jan 2019

03Safety and incidents

What has gone wrong

Dec 2019
Medtronic warned that some Mazor X robots could come loose from the operating table and fall. It had seven complaints and no reported injuries. MassDevice, 7 Jan 2020
10 Dec 2025
Class 2 FDA recall of the Mazor X system: software errors could lead to wrong tool position in spine surgery. 549 systems affected. FDA recall record, posted 16 Jan 2026

In clinical trials

4 registered trials

From ClinicalTrials.gov, read every day.

FDA record

16 FDA records

Clearances and recalls from the FDA's own database.

All 16 records

How we placed it

The rule, not an opinion

Stages are worked out by published rules from the dated milestones above. We never rate robots, and no maker can pay to change a stage.

5
Regulator-cleared or mass marketThis robot
A regulator has cleared it where approval applies: FDA clearance or approval for a medical robot, a permit to run with no one aboard for a self-driving vehicle, or an FAA approval for routine drone flights. Or: Widely sold: sales in the hundreds of thousands, or a product category you can buy in ordinary shops.
Placed by: The FDA cleared the Mazor X Stealth Edition through the 510(k) route (Nov 2018).
4
Paying customers
Delivered to customers who pay for it, beyond a trial, or a paid service the public can use.
3
Pilot
Working with a named customer in a real setting, as a trial.
2
Pre-orders
Orders, reservations or deposits taken, with nothing delivered yet.
1
Demo only
Shown in videos, staged events or a factory, with no units working for customers.

What we couldn't confirm. The sources found do not say whether Stealth AXiS replaces Mazor X. The 549 figure is the recall's quantity in commerce, not a confirmed total installed base.

Sources

Cite this page

Robotics Verdict. “Mazor X Stealth Edition (Medtronic (originally Mazor Robotics, Israel)): how far has it got?” roboticsverdict.com/robots/medtronic-mazor. Checked 19 October 2026.