Surgalign Announces FDA Clearance for Spine Device

DEERFIELD – Surgalign Holdings Inc. said the U.S. Food and Drug Administration has approved a new medical device authorization for its spinal fixation system.

The Cortera Spinal Fixation System will be Surgalign’s flagship product and a key part of its portfolio designed to drive the company’s future growth over the next 10 years, he said. The medical device company aims to gain market share in the estimated $2.2 billion posterior fixation market in the United States

At its core, Cortera is a rod pedicle screw system used in back surgeries with a feature-rich design that maintains a relatively low profile and a newly designed locking mechanism, Surgalign said.

“The Cortera system is a testament to the backbone engineering talent and expertise that we have assembled in a very short time, as we went from zero engineers in the US following (our) RTI divestiture there. is two years old, to about 30 today,” said Terry Rich, President and CEO of Surgalign.