Accelus has received U.S. Food and Drug Administration (FDA) 510(k) clearance for MRI compatibility of its FlareHawk Interbody Fusion System.

The clearance follows rigorous safety testing and modeling studies, which showed the FlareHawk implants meet established ASTM standards for magnetic resonance imaging (MRI) compatibility under certain scanning conditions. The testing evaluated magnetic field interactions, radiofrequency-induced heating, and image artifacts, establishing the FlareHawk implants’ safety in various MRI environments.

Patients implanted with the FlareHawk Interbody Fusion System may be safely scanned under conditions outlined in the FlareHawk Instructions for Use (IFU) and at www.accelusinc.com/mrisafety.

“The ability to confidently undergo MRI scans is an important factor for both patients and surgeons when selecting spinal implants,” Accelus President/CEO Kevin McGann said. “This additional clearance reinforces our commitment to offering safe, high-quality solutions that address the real-world needs of the spine surgery community.”

FlareHawk implants are designed with a PEEK shell, a titanium surface technology embedded into the shell substrate, and an internal titanium shim. These implants feature a small insertion profile that minimizes neural retraction during placement, followed by multidirectional expansion in height, width, and lordosis. This design is intended to reduce the risk of subsidence, restore foraminal height, and re-establish sagittal balance.

Accelus’s product portfolio also includes the LineSider Spinal System, featuring modular cortical screws, and the Toro-L Interbody Fusion System. The company’s differentiated implants and instruments support various minimally invasive techniques suitable for both hospital and ambulatory surgery center (ASC) environments, with the goal of preserving patient anatomy, enhancing procedural efficiency, and promoting long-term spinal stability.

To date, more than 32,000 FlareHawk cages have been implanted in 25 countries worldwide.

Accelus develops expandable spinal implant solutions. Its advanced “Adaptive Geometry” technologies specifically are designed for transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF), endoscopic-assisted, percutaneous, and lateral spine surgeries.