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Tenon Medical announces FDA 510(k) clearance for sacroiliac joint fusion system

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Tenon Medical Inc. announced its Catamaran sacroiliac joint fixation system has received FDA 510(k) clearance.

According to a company press release, the system was designed for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The system is reportedly the first, patented, single implant sacroiliac joint (SIJ) fusion system using a posterior approach for minimal tissue disruption. The system allows surgeons to use either a navigated procedure or fluoroscopic imaging.

“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,” said Tenon CEO Kal Mentak, MD. “Our unique minimally invasive approach is designed to take less time and fewer surgical steps and represents a landmark innovation for SIJ fusion surgery benefiting patients, surgeons, facilities and payers.”

Reference:

www.tctig.com