Tenon Medical Gains FDA Clearance for Catamaran Sacroiliac Joint Fixation

By Julie A. Vetalice

Tenon Medical received FDA 510(k) clearance to market the Catamaran™ Sacroiliac Joint Fixation system (CAT SIJ), indicated for sacroiliac joint fusion to treat sacroiliac joint disruptions and degenerative sacroilitis. CAT SIJ is reportedly the first patented single implant SIJ fusion system to employ a posterior approach for minimal tissue disruption.

In late 2016, Tenon was granted U.S. Patent No. 9,492,284, System for Sacro-iliac Stabilization, which covers a novel minimally invasive posterior approach fusion system to stabilize the SIJ. The company has since filed for additional compositions.

Sources: Tenon Medical, Inc.; USPTO.gov

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Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory