PALM BEACH GARDENS, Fla., June 12, 2025 – Accelus, a privately held medical technology company committed to becoming the global market leader in expandable spinal implant technologies, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its FlareHawk Interbody Fusion System to be safely subjected to MRI scanning in certain conditions.
The clearance follows rigorous safety testing and modeling studies, which demonstrated that the FlareHawk implants meet established ASTM standards for MRI compatibility under certain scanning conditions. The testing evaluated magnetic field interactions, radiofrequency-induced heating, and image artifacts, establishing the safety of FlareHawk implants in various MRI environments.
Patients implanted with the FlareHawk Interbody Fusion System may be safely scanned under the 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,” said Kevin McGann, President and CEO of Accelus. “This additional clearance reinforces our commitment to offering safe, high-quality solutions that address the real-world needs of the spine surgery community.”
The FlareHawk family of implants is uniquely 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 a wide range of 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. By prioritizing surgeon-driven innovation and scalable technologies, Accelus continues to provide next-generation implants that align with the evolving standards of modern spine care.
About Accelus
Accelus, a worldwide leader in expandable spinal implant technology, is dedicated to enhancing surgical procedures and patient outcomes through innovative spinal solutions. The company’s commitment to excellence is evident in its advanced “Adaptive Geometry” technologies specifically designed for transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF), endoscopic-assisted, percutaneous, and lateral spine surgeries. For more information on Accelus and its innovative product portfolio, please visit www.accelusinc.com.
