Surgalign has announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its Cortera spinal fixation system.
“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,” Terry Rich, president and CEO of Surgalign, told the press. “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 is a 5.5/6 mm rod pedicle screw system with both open and MIS (minimally invasive surgical) modules. It has a feature-rich screw design with a comparatively low profile and newly designed locking mechanism.
“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.”
“What excites me about Cortera is how the system was forward-thinking to the technology evolution we are witnessing now in spine surgery,” said Dr. Craig Meyer, a Cedars-Sinai MIS Fellowship trained spine surgeon. “This is an exciting time to be a spine surgeon and hardware systems like Cortera will facilitate our rapid evolution of techniques to perform spinal surgery when integrated with technologies like HOLO Portal.”
Surgalign will integrate Cortera with its HOLO Portal surgical guidance system for an optimal user experience for pedicle screw navigation. The firm is planning to add further implants and instruments to Cortera over the next few years to expand the system’s applications into a majority of posterior spinal fixation procedures.