SAIL Fusion Gains FDA 510(k) for BowTie Sacroiliac Fusion

SAIL Fusion received FDA clearance to market its novel BowTie Sacroiliac (SI) Fusion System. BowTie is reportedly the first SI fusion technology to be based on validated joint fusion principles established by the AO Foundation, and is now the only commercially available device that incorporates both intra‑articular and transfixing components.

The MIS BowTie technology and its posterior-inferior surgical technique are designed to minimize tissue disruption, prepare the joint and provide rigid fixation to enable arthrodesis. The device features a bowtie shape as well as integrated transfixation and iliac screws to maximize rigidity. It also utilizes a proprietary porous structure and roughened surface technology to facilitate osteointegration.

The system will be launched to a select group of initial surgeons in preparation for a greater expansion in the coming months.

David Jansen, the President & CEO of SAIL, said, “Our approach challenges the prevailing trend of lateral fixation that is more appropriate for stabilization rather than true joint fusion. To achieve this, BowTie leverages decades of clinically validated arthrodesis methods that have been applied to nearly every other joint.”

Mr. Jansen added, “The BowTie device, with its trademark bowtie shape, was designed to help achieve the AO’s other significant joint fusion principle of rigidly fixating the joint to provide a biologic environment favorable for bone growth. We reinforced its rigidity by adding both integrated iliac and transfixation screws to address the complex biomechanics of the pelvis. We are pleased that BowTie’s multiplanar approach to fixating the joint also closely aligns with both the Transfixation and the recently established Intra-Articular CPT codes. This is an exciting time for surgeons, and especially for patients struggling with chronic SI joint pain.”

Source: SAIL Fusion