SIJ Fusion System

Minimally-Invasive Sacroiliac Joint Fusion System

Executive Summary

Chronic low back pain is the second most common cause of disability in U.S. adults, 15% to 30% which can be attributed to the sacroiliac joint (SIJ). Since first being approved by the FDA in 2008, minimally-invasive SIJ fusion surgery has become the standard of care for surgical treatment of SIJ pain. In 2020, in the U.S. alone, tens of thousands of patients benefited from the procedure and – with demand growing at upwards of 15% to 20%+ per year – 200,000+ patients, annually, could benefit.

Yet surgeons indicate that current, surgical solutions still might benefit from a more optimal combination of (1) fast, thorough decortication of the joint space, (2) powerful controllable compression, and (3) procedural efficiency throughout.

To address this clinical and market need, Stephen P. Kalhorn, M.D. – neurosurgeon at the Medical University of South Carolina – has partnered with ZIAN to develop and commercialize a minimally-invasive, SIJ Fusion System.

In addition to other features, the System is designed to be manufactured in 3D-printed titanium alloy and to differentially promote bony fusion by allowing for fast, thorough, integrated decortication and powerful, controllable compression.

SIJ Fusion System

Project Status

Available for exclusive licensing or acquisition

The System’s implants and instruments are rapidly approaching pre-regulatory design freeze, after four internal cadaver labs, two external cadaver labs, and several rounds of 3rd party ASTM testing – including two run-outs in dynamic shear.

Extensive, iterative system upgrades informed by: (1) cadaveric and bench-top testing, (2) extensive feedback from neurosurgeons and orthopedic surgeons, (3) extensive feedback from industry, via conversations with 20+ potential partners.

Patent pending