Globus Medical Receives FDA 510(k) Clearance for Excelsius GPS Robotic System

By Julie A. Vetalice

Globus Medical (GMED) received FDA 510(k) clearance to market the Excelsius GPS™ robotic guidance and navigation system.

The platform, which utilizes only Globus implants and instruments, can support minimally invasive or open orthopaedic procedures including screw placement in spine and orthopaedic surgery.

GMED acquired Excelsius Surgical in early 2014 and filed for FDA clearance of the robotic tool at the end of 2016; CE Mark Approval was secured at the beginning of 1Q17. A slight delay to the expected 2Q17 FDA clearance occurred due to an FDA letter, indicating that the company had not sufficiently addressed questions on its submission. However, GMED submitted a revised filing and expressed confidence in a 3Q17 clearance.

Despite the brief delay, the company has maintained its full-year guidance of $625MM and is just shy of 50% of the way there, having posted 1H17 revenue of $308.2MM.

GMED's 2Q17 acquisition of KB Medical is expected to fuel future improvements to next iterations of its robotic technology.

Sources: Globus Medical, Inc.; ORTHOWORLD Inc.

Product Labels: Robot-Assisted Systems

Tags: 510(k) Clearance, Regulatory