Globus Medical obtains FDA nod for ortho robot

Globus Medical has received FDA 510(k) clearance for its ExcelsiusFlex orthopedic robot ahead of schedule, according to an agency posting. The clearance was anticipated later in the third quarter following Globus' submission for a reconstruction robot.

Globus Medical currently sells the ExcelsiusGPS robotic navigation system for spine surgeries and an imaging platform, driving a 27% year-over-year growth to $32 million in its enabling technology segment in the first quarter. The company recently acquired NuVasive and its Pulse spine surgery platform for $3.1 billion.

With the ExcelsiusFlex clearance, Globus plans to expand into the global hip and knee market, integrating its imaging, navigation, and robotics expertise. The company aims to differentiate its robot in a commoditized implant market.

Initial sales in 2024 are expected to be minimal, with gradual market share growth anticipated annually in the U.S. reconstruction market.