SI-BONE Receives FDA Clearance For Its iFuse Granite Onyx System

SI-BONE, Inc. (NASDAQ: SIBN) has received FDA 510(k) clearance for its iFuse Granite Onyx System, marking the company's first product aimed at addressing compromised bone outside the pelvis. This innovation targets loosening at the upper and lower instrumented vertebrae in spinal fusion constructs, which affects up to 27% of cases, particularly in patients with low bone density. The Onyx system is part of SI-BONE's 3D-printed bone integration platform, expanding its market opportunities.