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FDA clears Sail Fusion’s BowTie Sacroiliac Fusion System

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.

“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.”

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