FDA OKs Accelus’ FlareHawk TiHawk11 Interbodies

Minimally invasive spine surgery firm Accelus gained U.S. Food and Drug Administration 510(k) clearance for its FlareHawk TiHawk11 interbody fusion system, the latest addition to its flagship FlareHawk spinal cage portfolio.
 
The interbody has an 11mm-wide insertion profile and expands to 17 x 14mm, providing 70% more footprint than a 10mm-wide interbody of identical length. The larger footprint boosts stability and allows post-packing bone graft after expansion to increase volume.
 
TiHawk11 cages are made from a titanium and PEEK bonding process that deposits a uniform, 0.5 micron-thick titanium layer at the bonding surface, so the PEEK and titanium strongly adhere without fluoroscopic visualization loss often associated with titanium implants. The combination also may present a modulus that more closely mimics bone.
 
“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,” Dr. Peter Derman, a minimally invasive and endoscopic spine surgeon at Texas Back Institute who was involved in TiHawk11’s design told the press. “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!”
 
“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.”
 
Accelus launched its TiHawk7 interbody cages for endoscopic and minimally invasive lumbar fusion procedures earlier this week.