SI-BONE, Inc. (NASDAQ:SIBN), the global leader in developing procedural solutions to address clinical challenges associated with compromised bone, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the iFuse Granite Onyx System (Onyx). This is SI-BONE’s first product addressing the problem of compromised bone which is intended for use outside the pelvis, expanding the market opportunity for the company’s 3D-printed bone integration platform.

SI-BONE is redefining spinal fusion with Onyx, an innovation designed to address loosening at the upper and lower instrumented vertebrae (UIV and LIV, respectively) of a spinal fusion construct. Loosening occurs in the UIV and LIV in as many as 27% of fusion constructs.1,2 The loosening risk is elevated for patients with low bone density, contributing to higher revision rates and cost of care.1,3 Onyx was designed to address this issue in fusion procedures with the needs of patients with poor bone quality in mind.