PALM BEACH GARDENS, Fla., May 12, 2022 – Accelus 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.
Toro-L features an insertion profile that is 14mm wide, expanding to the implant’s full width of either 21 or 24mm before further expanding to the surgeon’s desired height of up to 16mm. The insertion height and fully expanded height are relative to the lordosis of the implant. The implant will initially be offered with a 10-degree lordotic option during alpha launch with 5-degree and 15-degree lordotic options offered upon full commercial launch. The implant has 3D-printed endplates, which have a roughened surface where the implant interfaces with bone due to the additive manufacturing process.
In addition, the Toro-L system is equipped with an inlet retractor. Although the inlet retractor has a feature-rich split-tube design, the Toro-L system was created such that the surgeon should never have to open the tube to perform the surgery. Unique and proprietary disc removal instrumentation, along with traditional curettes, rasps, scrapers, kerrisons, and pituitaries, give the surgeon the ability to fully evacuate the disc space and accommodate the full-width footprint of the expanded Toro-L implant. The system also features an optimized post-pack graft delivery method that is fast and efficient.
“Toro-L was designed to offload the pressure on the innervated posterior psoas muscle without sacrificing footprint,” said Chris Walsh, CEO and Co-Founder of Accelus. “Our design team created an implant with a massive footprint that still preserves bony, nerve and ligamentous tissue. We strongly believe Toro-L will obviate many of the clinical challenges seen at the L4-L5 levels in the current lateral market.”
