First patented single implant sacroiliac joint fusion system receives FDA clearance

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The Catamaran sacroiliac joint fixation system

The US Food and Drug Administration (FDA) have granted clearance for the Catamaran sacroiliac joint fixation system (Tenon Medical) specifically indicated for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroilitis.

The Catamaran sacroiliac joint fixation system is the first patented single implant sacroiliac joint fusion system using a true posterior approach for minimal tissue disruption.

“With the FDA 510(k) clearance of the Catamaran sacroiliac joint fixation system, Tenon now has the first patented single implant SIJ fusion system that allows surgeons to use either a navigated procedure or fluoroscopic imaging providing flexibility in access and visibility.  The implant is designed to allow for bone graft materials to be loaded and delivered to the SIJ before and after implant placement to promote fusion of the SIJ,” says Tenon CEO Kal Mentak.

“Our unique minimally invasive approach is designed to take less time and fewer surgical steps and represents a landmark innovation for sacroiliac joint fusion surgery benefiting patients, surgeons, facilities, and payers.”

In November 2016, Tenon Medical was granted the first US patent covering a novel minimally invasive posterior approach fusion system to stabilise the sacroiliac joint. The company has since filed for additional compositions.

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