Globus Medical Gains 510(k) Approval for Orthopaedics Robot

The FDA has granted Globus Medical 510(k) approval for its ExcelsiusFlex orthopaedics robot.

The business is currently seeking to diversify into joint repair techniques. When CEO, Dan Scavilla, first announced the robot’s arrival to investors in May, he said it would be “one of the most exciting things we’ll get out of the door this year.” He also mentioned that the business was accumulating inventory in anticipation of a launch as it anticipated FDA permission.

The invention will be “In a different marketplace that will allow us to have more volume ramp-up of our implants of knees and hips,” Scavilla stated.

Globus will be able to enter the worldwide hip and knee market and offer another enabling technology thanks to the approval that came in sooner than anticipated, according to RBC Capital Markets analyst. Globus anticipates that by “leveraging its imaging, navigation, and robotics expertise in a market where implants are fairly commoditized,” their reconstruction robot will differentiate itself from rivals.