SI-BONE Wins FDA 510(k) Clearance for iFuse Granite Onyx Spinal Fusion System

SI-BONE, Inc. (SIBN) announced on September 29, 2026, that the U.S. Food and Drug Administration granted 510(k) clearance for its iFuse Granite Onyx System, expanding the company's compromised bone franchise beyond the pelvis into spinal fusion procedures. The system addresses screw loosening at the upper and lower instrumented vertebrae (UIV and LIV), a complication the company says occurs in as many as 27% of fusion constructs, with elevated risk in patients with low bone density. Onyx features a bone-density-specific surface and anatomy-specific thread form designed to promote rapid osseointegration and reduce micromotion. It is SI-BONE's first product addressing compromised bone intended for use outside the pelvis, and its third platform to receive FDA Breakthrough Device designation. SIBN closed September 28 at $18.76, up 0.91%. Shares rose 1.28% to $19 in overnight trading.