SI-Bone receives 510(k) clearance for updated iFuse indication


The US Food and Drug Administration (FDA) has cleared a 510(k) to allow modification of Si-Bone’s indication statement for iFuse, noting that clinical studies have demonstrated treatment with the system can improve pain, patient function and quality of life.

The revised indication statement is based on safety and effectiveness data from retrospective studies as well as three prospective clinical trials.

The iFuse implants have a patented triangular shape, designed to provide 31 times the rotational resistance of a screw. According to a company release, it is the only commercially available sacroiliac joint fusion device with published clinical evidence—including three large multicentre prospective studies—that demonstrates safety and effectiveness. Currently, there are more than 40 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and economic benefits of iFuse.