Surgalign announces FDA 510(k) clearance of the Cortera spinal fixation system

Cortera spinal fixation system (Surgalign)

Surgalign has received US Food and Drug Administration (FDA) 510(k) clearance of its Cortera spinal fixation system— a 5.5/6mm rod pedicle screw system, that has both open and minimally invasive modules.

Terry Rich, president and CEO of 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 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.”

According to the company, the Cortera system boasts a feature-rich screw design that maintains a comparatively low profile and a newly designed locking mechanism.

Jeremy Smith, chief of spine at Hoag Orthopedic Institute (Irvine, USA), commented: “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.”

The company will integrate the Cortera system with the HOLO Portal surgical guidance system in an effort to create an unrivalled 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.

“What excites me about Cortera is how the system was forward-thinking to the technology evolution we are witnessing now in spine surgery,” added Craig Meyer, a Cedars-Sinai MIS fellowship trained spine surgeon, practicing in Columbia, USA. “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.”


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