Tenon Medical (NASDAQ:TNON) has announced that the FDA has granted 510(k) clearance for its SImmetry+ SI Joint Fusion System indicated for sacroiliac (SI) joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, providing physicians with treatment options engrained in established fusion principles.
According to Tenon, the company is finalizing preparation for the initial alpha launch of the SImmetry+ targeting a launch by the end of 2025. The alpha will provide important initial user feedback from a select group of physician users to support a broader market introduction in the coming months.
In a statement, Steven M. Foster, president and CEO of Tenon, commented, “The FDA clearance of SImmetry+ marks a significant inflection point in Tenon’s growth trajectory. By expanding our portfolio to include both the Catamaran and SImmetry+ systems, we have created a differentiated market position with multiple approaches to SI joint fusion backed by proven clinical outcomes including pain reduction, patient satisfaction, and independent confirmation of bridging bone fusion across the joint. This unique competitive advantage strengthens our ability to drive adoption, increase procedure volumes, and capture a larger share of this rapidly expanding market, all of which supports long-term value creation for our shareholders. We look forward to initiating our alpha launch of SImmetry and collaborating with our initial physician users to gain their feedback on performance and outcomes.”
