Accelus FlareHawk Interbody Fusion System Cleared

Accelus has received 510(k) marketing clearance from the FDA for its FlareHawk TiHawk 11 interbody fusion system.

The latest in the company’s FlareHawk line of spinal fusion cages, the devices are now available in a larger footprint with titanium at the bony interface. The TiHawk11 is 11mm wide at insertion but it expands to 17mm in width and 14mm in height, providing 70 percent more surface area than a 10mm-wide interbody device of identical length.

The larger cage dimensions help increase stability and provide the ability to insert more bone graft, the company said.

The cages are manufactured using a 0.5-micron-thick layer of titanium over a polyether ether ketone (PEEK) polymer, which avoids the loss of fluoroscopic visualization often associated with titanium implants.