Aurora Spine has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance for its Aero facet fusion system.

The Aero MIS (minimally invasive surgical) facet fusion system is a patent-pending device for patients suffering from facet joint-related pain or instability. It was cleared for use from spinal levels C2 to S1 and can be used either a standalone facet fusion procedure or as an adjunct to larger spinal fusions.

Aurora said Aero was engineered for earlier use in the care continuum and is ideal for patients with mechanical back pain, minor instability, or degenerative joint disease who haven’t responded to less invasive therapies. The system’s instrumentation and implant technology were designed to promote bone fusion while minimizing soft tissue disruption.

The first surgeries using Aero are planned to begin in late Q3 2025. Several leading spine surgeons were already selected to participate in an initial clinical study to validate the device’s clinical outcomes and long-term benefits.

“We are thrilled to receive FDA clearance for the Aero system, which represents the next evolution of our innovation pipeline,” said Trent Northcutt, president and CEO of Aurora Spine. “This system was purpose-built for physicians treating facet joint issues and offers a streamlined, user-friendly solution. Like all Aurora products, Aero balances clinical efficacy with procedural simplicity. Early feedback from surgeon testing has been overwhelmingly positive, and we believe Aero has the potential to become a significant growth driver for Aurora.”

In January, the company announced that it promoted Matt Paxton to executive VP of sales and Katelyn Sims to area VP of commercialization and key accounts.