FDA 510(k) Clearance for Newest FlareHawk Interbody Fusion System

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of Integrity Implants Inc., d/b/a/ Accelus’ FlareHawk TiHawk™11 Interbody Fusion System.

According to the FDA 510(k) document, the FlareHawk Interbody Fusion System is “an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1.”

Per the FDA 510(k) document, the FlareHawk Interbody Fusion System is indicated for “spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy.”

“DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.”

In order to qualify for shorter and earlier 510(k) clearance the device must be substantially equivalent to a predicate device. According to the FDA 510(k) document, the “FlareHawk Interbody Fusion System has substantially similar fundamental scientific technology as the predicate FlareHawk Interbody Fusion System.” This includes its rectangular frame, the shim component, the shell component being manufactured from PEEK, and the tapered front end of the shim component that inserts into and expands the shell component.

Palm Beach Gardens, Florida-based Accelus offers a portfolio of spinal fusion cages. TiHawk11 is unique because of its larger footprint. According to the company, “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.”

Accelus also explains that “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.”

Palm Beach Gardens, Florida-based Integrity Implants Inc. submitted the 510(k) application to the FDA. However, the product belongs to the Accelus portfolio of products. Founded in 2021, Accelus is a combination of Integrity Implants and Fusion Robotics, LLC.

Accelus CEO and Co-Founder Chris Walsh commented, in part, “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.”