Regulator
The FDA cleared ExcelsiusGPS through the 510(k) route (K171651) for open and minimally invasive spine and orthopedic surgery.
A regulator's decision · Sets ExcelsiusGPS's stage
What the source says
“Globus Medical (NYSE:GMED) said today that it won 510(k) clearance from the FDA for its long-awaited Excelsius robot-assisted surgery platform, which is designed to integrate intra-operative CT and fluoroscopic imaging technologies.”
What it means
ExcelsiusGPS, from Globus Medical, 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 ExcelsiusGPS
- The FDA cleared a sister robot, ExcelsiusFlex, for knee replacement and other joint surgery.
- Globus recalled 9 kits of an add-on part used with ExcelsiusGPS for X-ray imaging, because a calibration error could make the navigation inaccurate and a screw could be placed in the wrong spot. The FDA listed it as a Class 1 recall (its most serious kind).
- Globus said surgeons had done more than 20,000 spine operations with ExcelsiusGPS.
- The first European operation with ExcelsiusGPS took place at Metropolitan Hospital in Athens, Greece.
- Globus began selling ExcelsiusGPS in the US at the end of 2017.