Surgalign announces FDA clearance of spine device

DEERFIELD - Surgalign Holdings Inc. said the U.S. Food and Drug Administration has approved new medical device clearance of its spinal fixation system.

The Cortera Spinal Fixation System will be Surgalign's flagship product and a key piece in its portfolio designed to drive the company's future growth over the next 10 years, it said. The medical device company intends to gain market share in the estimated $2.2 billion posterior fixation market in the U.S.

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

"The Cortera system is a testament to the spine engineering talent and expertise we've assembled in very short order, as we moved from zero engineers in the United States following (our) RTI divestiture two years ago, to approximately 30 today," said Terry Rich, president and CEO of Surgalign.