US-based spine solutions provider Surgalign Holdings has received the US Food and Drug Administration (FDA) 510(k) approval for the Cortera spinal fixation system.
The Cortera is a 5.5/6.0mm rod pedicle screw system, with both open and MIS modules.
It comes with a feature-rich screw design that maintains a comparatively low profile and a newly designed locking mechanism, said the company.
Surgalign aims to integrate the Cortera system with its HOLO Portal surgical guidance system designed to enhance the user experience for pedicle screw navigation.
The new spinal fixation system is designed to enhance adoption in the current spine market, along with evolving techniques and technology, said the medical device maker.
Surgalign president and CEO Terry Rich 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 the RTI divestiture two years ago, to approximately 30 today.
“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.”
By offering advanced technologies to facilitate spinal fusion procedures, Cortera is expected to help advance the adoption of its HOLO Portal surgical guidance system.
Surgalign said that a limited market release of the Cortera spinal fixation system would positively contribute to its Q4 2022 results and beyond.
Furthermore, the company plans to expand its Cortera system with additional implants and instruments for the majority of posterior fixation spinal procedures, in the coming three to four years.
Hoag Orthopedic Institute spine chief Jeremy Smith said: “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.
“I find the system has an evolved sophistication that provides a high-quality user experience and enhanced clinical performance in challenging pathologies.”