SI-BONE, Inc. is a medical device company, which engages in the provision of a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint for treatment of musculoskeletal disorders of the sacropelvic anatomy. It offers a proprietary minimally invasive surgical implant system, called iFuse, used to fuse the sacroiliac joint to treat sacroiliac joint dysfunction that often causes severe lower back pain. The company was founded by Mark A. Reiley and Jeffrey W. Dunn on March 18, 2008 and is headquartered in Santa Clara, CA.
Clinical Trials
13
4 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2008
Active, not recruiting
3
23.1%
Completed
6
46.1%
Not yet recruiting
1
7.7%
Recruiting
1
7.7%
Terminated
2
15.4%
No approval data available
- SI-BONE initiated a voluntary recall of 98 iFuse TORQ implants on August 21, 2026, after tube packaging made between May 4 and May 15 failed sterile barrier criteria. - Two recalled implants had already been used in patients; physicians were notified and no infections or adverse events have been reported. - About 3,900 implants including recalled lots and affected inventory will be repackaged and re-sterilized, with costs of up to roughly $150,000 expected in the third and fourth quarters.
- Smith+Nephew has signed a distribution agreement with SI-BONE to offer the innovative iFuse TORQ portfolio for percutaneous pelvic fracture fixation procedures. - The partnership centers on iFuse TORQ TNT, which received FDA Breakthrough Device Designation for more effective pelvic fracture treatment compared to traditional cannulated screws. - The collaboration expands Smith+Nephew's trauma portfolio and strengthens its position in high-frequency, high-impact trauma procedures through SI-BONE's established technology platform. - iFuse TORQ TNT is eligible for Medicare New Technology Add-on Payment, potentially providing up to $4,136 in additional reimbursement per procedure for hospitals.
- SI-BONE's iFuse TORQ TNT implant system has received FDA 510(k) clearance, offering a novel solution for pelvic fragility fractures. - The TNT system is designed to address the specific anatomical and bone mineral density needs of the sacrum and ilium, potentially improving treatment outcomes. - TNT's design aims to enhance early fixation and reduce screw backout, facilitating earlier patient weight-bearing and mobilization post-surgery. - The sacroiliac joint fusion market is projected to grow significantly, with SI-BONE's advancement positioning it well to address unmet clinical needs.
