SI-BONE Receives 510(k) Clearance on Updated Indication for iFuse Implant

By Julie A. Vetalice

SI-BONE received FDA 510(k) clearance of a modified indication for the iFuse Implant System®, noting that clinical studies have demonstrated its ability to improve pain, patient function and quality of life. The revised indication is based on safety and effectiveness data from retrospective studies as well as three prospective clinical trials.

To date, >21,000 iFuse procedures have been performed worldwide to treat sacroiliac joint dysfunction.

Sources: SI-BONE, Inc.; ORTHOWORLD Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory