Accelus Receives U.S. FDA 510(k) Clearance for its FlareHawk TiHawk11 Interbody Fusion System

Accelus, a privately held medical technology company focused on accelerating the adoption of minimally invasive surgery (MIS) as the standard of care in spine, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its FlareHawk TiHawk™11 Interbody Fusion System.

TiHawk11 is the latest addition to Accelus’s flagship FlareHawk® portfolio of spinal fusion cages, which are now available in a larger footprint with titanium at the bony interface.

TiHawk11 features an 11mm-wide insertion profile and expands to 17mm in width and 14mm in height, providing 70% more footprint than a 10mm-wide interbody device of identical length. This larger interbody footprint is designed to increase stability and provide the ability to post-pack bone graft after expanding to increase graft volume.

“TiHawk11 is even more of a great thing. These interbody cages feature multi-planar expansion, adaptive geometry, and open architecture designed to facilitate safer insertion and deployment–unique properties that can minimize subsidence and maximize fusion,” said Dr. Peter Derman, a minimally invasive and endoscopic spine surgeon at Texas Back Institute who was involved in the design of TiHawk11.

He added, “By expanding on their family of TiHawk offerings to include this even larger footprint, Accelus has provided surgeons with a comprehensive set of devices for any transforaminal or posterior lumbar interbody fusion procedure. I’m so excited to get this implant in my hands!”

TiHawk11 cages are manufactured using an innovative titanium and PEEK bonding process that deposits a uniform, 0.5-micron-thick layer of titanium at the bonding interface. This provides strong adhesion between the PEEK and titanium without the loss of fluoroscopic visualization often associated with titanium implants. The combination of PEEK and titanium may also permit a modulus more similar to bone.

“I’m incredibly proud of the advances in our new TiHawk11 system, which combines the small insertion profile of FlareHawk with the largest footprint we’ve offered surgeons to date,” said Chris Walsh, CEO and Co-Founder of Accelus. “These features, in combination with the favorable characteristics of PEEK with titanium, enables TiHawk11 to truly encompass our mission of helping accelerate the move to minimally invasive surgery and provide another great tool for spine surgeons to have available for their patients.”

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