Sail Fusion today announced it received FDA 510(k) clearance for its BowTie Sacroiliac Fusion System.
The Del Mar, California-based sacroiliac device company designed the device to incorporate intra-articular and transfixing components. BowTie minimizes tissue disruption, thoroughly prepares the joint, and provides rigid fixation to enable robust arthrodesis.
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“There hasn’t been meaningful differentiation in the SI fusion market for many years,” President and CEO David Jansen said in a news release. “By interviewing hundreds of surgeons, we were able to identify an unmet need for robust fixation built on proven AO principles. 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.”
The MIS BowTie device has a bowtie shape and integrated transfixation with iliac screws to maximize rigidity. It uses a porous structure and roughened surface technology to facilitate osteointegration.
“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,” Jansen said. “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.”
