SI-BONE, Inc. Receives 510(k) Clearance from the FDA for iFuse Bedrock Granite, a Breakthrough Pelvic Fixation and Fusion Technology


SANTA CLARA, Calif., May 31, 2022 (GLOBE NEWSWIRE) — SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the Sacropelvic Anatomy, Announces FDA 510(k) Premarket Clearance for the iFuse Bedrock Granite (Granite) Implant System. The Granite implant provides sacroiliac fusion and sacropelvic fixation as a fundamental component of segmental spinal fusion.

This clearance follows the Food & Drug Administration’s (FDA) earlier designation of granite as a Breakthrough Device (BDD) and, more recently, a proposal from the Centers for Medicare and Medicaid Services (CMS) for a new technology Add -on Payment (NTAP). CMS has also released a new unique ICD-10 “Section X” procedure coding technology allowing hospitals to flag NTAP-eligible cases that use granite as an internal fixation device with tulip connector, for sacro joint fusion. -open or percutaneous iliac and sacropelvic fixation.

According to Christopher Shaffrey, MD, head of the spine division at Duke University, “Pedicle screws were designed for pedicles. When spine surgeons began to anchor screws in the pelvis to reinforce the base of vertebral constructs, surgeons simply used longer, larger diameter pedicle screws in the iliac and sacroalar trajectories. Numerous clinical studies have shown significant problems with this strategy; loosening of screws, postoperative sacroiliac joint pain and hardware failure. With Granite, there is now a device designed for the specific requirements of the sacropelvic anatomy. I am very happy for the many patients who will benefit from this new technology.

“Reoperations after spinal deformity surgery in adults occur in more than 20% of cases. It is an expensive problem in terms of time, cost and patient discomfort. It is Refreshing to see that CMS recently proposed an NTAP for SI-BONE’s iFuse Bedrock Granite. Adoption of this product should result in fewer re-operations, better patient outcomes and lower system costs,” said Scott Alexander. , former Vice President of Innovation at Mercy Health System.

“We are delighted to receive 510(k) clearance from the FDA to bring Granite to market. Anticipation has grown since the FDA rewarded BDD for its promise to provide more effective treatment than the current standard of care, and CMS’s recently proposed NTAP recognizing it as a new technology that can provide substantial clinical improvement. compared to therapies already available,” said Laura Francis, CEO of SI-BONE. “Based on early preclinical data from live animal studies suggesting significant bone growth and superior mechanical stability, internal studies showing significantly improved biomechanics, and early feedback from surgeons, we couldn’t be more excited about Granite’s clinical and commercial promise as a disruptive technology. unique.

About SI-BONE, Inc.
SI-BONE is a world technology leader for the surgical treatment of musculoskeletal disorders of the sacropelvic anatomy. Since 2009, when SI-BONE introduced the iFuse implant system for minimally invasive SI joint surgery, over 2,700 surgeons have performed a combined total of over 65,000 joint fusion procedures IF. A unique body of evidence, supporting the iFuse implant system, including two randomized controlled trials and more than 100 peer-reviewed publications, has enabled several government and private insurance payers to establish near universal coverage of the SI joint fusion procedure exclusively when performed with the iFuse Implant System. Backed by this exclusive reimbursement advantage, SI-BONE has actively leveraged its market leadership position over the past few years to pursue clinical research and develop and commercialize new surgical treatment solutions for SI-BONE pain. Joint, sacropelvic and pelvic fixation and pelvic trauma. For more information or to join our team, visit

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SI-BONE, iFuse Implant System, Bedrock and iFuse Bedrock Granite are registered trademarks of SI-BONE, Inc. ©2022 SI-BONE, Inc. All rights reserved.

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