FDA Grants Indication Clearance to Si-Bone’s iFuse Implant System

November 9, 2015

San Jose, Calif-based Si-Bone has received FDA clearance to include in the iFuse implant system’s indication statement that the device improved pain, patient function and quality of life at 12 months post-implantation.

This addition was based on a series of prospective and retrospective clinical studies, according to the company.

The iFuse system is a minimally invasive surgical device indicated for sacroiliac fusion for certain disorders of the sacroiliac joint. It uses titanium implants coated with a porous, titanium plasma spray that acts as an interference surface. — Michael Cipriano