Surgalign Gains FDA 510(k) Clearance of Cortera Spinal Fixation

Surgalign received FDA 510(k) clearance to market the Cortera™ Spinal Fixation System.

At its core, Cortera is a 5.5/6.0mm rod pedicle screw system that has both open and MIS modules. It includes a feature-rich screw design that maintains a comparatively low profile and a newly designed locking mechanism.

Surgalign will integrate Cortera with the HOLO Portal surgical guidance system designed to create an unrivaled user experience for pedicle screw navigation. The company is planning additional implants and instruments to add to the Cortera system over the next three to four years to expand applications of the system into a majority of posterior fixation spinal procedures.

Cortera’s limited market release is expected to positively contribute to 4Q22 results and in the coming years. The company expects that Cortera will help accelerate the adoption of the HOLO Portal surgical guidance system by offering surgeons and hospitals two state-of-the-art technologies packaged together to perform spinal fusion procedures.

“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 the RTI divestiture two years ago, to approximately 30 today,” stated Terry Rich, President and CEO of Surgalign. “Thanks to our team and incredible surgeon partners, we progressed from company inception to FDA 510(k) clearance with a very polished system in approximately 16 months. We are excited with the prospects the Cortera system brings to Surgalign, and those around the world who rely on our technology to drive better patient outcomes.”

Source: Surgalign Holdings, Inc.