Joint implant company Tenon Medical Inc reported on Wednesday the receipt of the 510(k) clearance from the US Food and Drug Administration (FDA) for the Catamaran Sacroiliac Joint Fixation System indicated for sacroiliac joint fusion for sacroiliac joint disruptions and degenerative sacroilitis.
The company said the Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) becomes the first patented single implant SIJ fusion system using a true posterior approach for minimal tissue disruption.
In 2016, the company received the first US patent for the novel minimally invasive posterior approach fusion system to stabilize the SIJ as well as filed for additional compositions.
Concurrently, the company now has the first patented US FDA approved 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," said Tenon CEO Dr. Kal Mentak.
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