The U.S. Food and Drug Administration (FDA) has granted 501(k) clearance for SI-BONE, Inc.’s iFuse Implant System to allow modification of its indication statement noting that clinical studies have demonstrated that treatment with system improves 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.
SI-BONE, a medical device company, pioneered the use of the iFuse system, a minimally invasive surgical device indicated for fusion for certain disorders of the sacroiliac (SI) joint.
The iFuse Implant has a patented triangular shape that provides 31 times the rotational resistance of a screw. Published clinical evidence regading the SI joint fusion device includes three multicenter prospective studies that demonstrate safety and effectiveness.
Currently, there are more than 40 peer reviewed publications supporting positive clinical outcomes, safety, biomechanics, and economic benefits of the implant, according to the company. The device has been used in more than 21,000 procedures performed worldwide.
SI-BONE, Inc., San Jose, CA, develops tools and products for patients with low back issues related to certain SI joint disorders.