Interbody Fusion System
FlareHawk7™ is a multidirectional expandable lumbar fusion device, featuring Accelus’s innovative Adaptive Geometry™, that can be inserted at a low profile of 7mm tall by 7mm wide before expanding up to 12mm tall and 11mm wide. Its minimal insertion profile and instrumentation is design to respect the patient’s anatomy while facilitating the surgeon’s preferred technique.
ENDOSCOPICALLY ASSISTED TLIF
Leverage endoscopic access while providing instruments necessary for directly visualizing disc preparation and delivering the implants.
MINIMALLY INVASIVE SURGERY (MIS) TLIF
Designed to provide safe access to the disc space through Kambin’s Triangle while also preserving normal anatomy.
Minimize the need for neural retraction by inserting an implant similar in profile to a pencil past the neural structures.
Patented curettes with modular handles and shaft diameters compatible with nearly every endoscope working channel on the market to deliver the opportunity for real-time visualization of the disc and endplate preparation.
Adjustable shaver blades provide disc height assessment while simultaneously prepping the disc space and endplates.
Trial the implant and distract the disc space without the need for multiple nerve root passes.
MINIMAL INSERTION PROFILE
FlareHawk’s insertion profile of 7mm H x 7mm W is smaller than several other commercially available expandable interbodies.
Adaptive Geometry technology delivers expansion in height (starting at 7mm, expanding to 12mm), width (starting at 7, expanding up to 11mm), and lordosis (0°, 6°).
SUBSTANTIAL GRAFT DELIVERY
Open architecture allows for substantial graft delivery post implantation into and through the implant into the surrounding disc space. Graft volume is only restricted by the volume of disc removed.
INDICATIONS FOR USE/INTENDED USE
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.