Surgalign (Nasdaq:SRGA) announced today that it received FDA 510(k) clearance for its Cortera spinal fixation system.
Deerfield, Illinois-based Surgalign said in a news release that the new flagship Cortera product represents a key piece to its portfolio in terms of driving the company’s future growth and ensuring market gains in the posterior fixation market.
“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,” said 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.”
Cortera, a 5.5/6mm rod pedicle screw system, offers both open and minimally invasive surgery (MIS) modules, plus a feature-rich screw design with a comparatively low profile and newly designed locking mechanism.
Surgalign designed Cortera to maximize adoption in the spine market, both today and in the future with evolving techniques and technologies. The company added that Cortera demonstrates the ways in which spinal implants will be deployed with technologies like its own HOLO Portal surgical guidance platform.
The company plans to integrate Cortera with HOLO Portal to create what it labeled “an unrivaled user experience for pedicle screw navigation.” Surgalign also has plans for additional implants and instruments to add to the system over the next few years to expand applications into a majority of posterior fixation spinal procedures.
Surgalign will offer Cortera in a limited market release, which it expects to positively contribute to its 2022 fourth-quarter results and in the coming years.
“Cortera resulted from the culmination of efforts by some of the most experienced and knowledgeable surgeons, engineers, and project team members in the world. The system is hands down the most precise, elegant and comprehensive screw that currently exists in my opinion,” said Dr. Jeremy Smith, chief of spine, Hoag Orthopedic Institute. “I find the system has an evolved sophistication that provides a high-quality user experience and enhanced clinical performance in challenging pathologies.”