Regulator
The FDA cleared the Mazor X Stealth Edition through the 510(k) route.
A regulator's decision · Sets Mazor X Stealth Edition's stage
What the source says
“The Mazor X Stealth Edition received 510(k) clearance from the FDA in November 2018,”
What it means
Mazor X Stealth Edition, from Medtronic (originally Mazor Robotics, Israel), is at stage 5 of 5 on our ladder: regulator-cleared or mass market. This event is one of the milestones that placed it there.
Human help: Our sources report it working without human help.
More on Mazor X Stealth Edition
- 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.
- Class 2 FDA recall of the Mazor X system: software errors could lead to wrong tool position in spine surgery. 549 systems affected.
- 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.
- Medtronic warned that some Mazor X robots could come loose from the operating table and fall. It had seven complaints and no reported injuries.
- Medtronic launched the Mazor X Stealth Edition in the US, and it began treating its first US patients.
- Before the Stealth Edition, Mazor already sold the Mazor X guidance system and an older spine robot called Renaissance.