Surgalign Scores FDA Approval For New Flagship Posterior Fixation Platform

Surgalign Holdings Inc SRGA announced FDA 510(k) clearance of the Cortera Spinal Fixation System, a key piece to the foundational portfolio designed to drive the company's future growth over the next ten years and to enable market share gains in the estimated $2.2 billion US posterior fixation market.
Cortera is a 5.5/6.0mm rod pedicle screw system with both open and MIS modules. The system boasts a feature-rich screw design that maintains a comparatively low profile and a newly designed locking mechanism.
The company will integrate the Cortera system with the HOLO Portal surgical guidance system. The company is planning additional implants and instruments to add to the Cortera system over the next 3-4 years to expand applications of the system into a majority of posterior fixation spinal procedures.
The Cortera Spinal Fixation System limited market release is expected to contribute to Q4 2022 results positively.
The company expects Cortera will help accelerate the adoption of the HOLO Portal surgical guidance system.
Price Action: SRGA shares are up 0.51% at $4.20 on the last check Wednesday.