SI-BONE Receives FDA Clearance for iFuse Granite Onyx Fixation Platform

Key Facts

SI-BONE received FDA 510(k) clearance for its iFuse Granite Onyx platform, designed for durable fixation in low-density bone. GlobeNewswire reported that the system addresses the needs of patients with compromised bone quality during spinal fusion procedures, marking a key expansion of the company's specialized bone franchise.

The clearance enables the company to extend its bone integration technology to areas beyond the pelvis, following the device's previous Breakthrough Device Designation. SIBN closed at $18.59 on September 25, 2026, having traded between a high of $18.76 and a low of $18.29 during that session.