5 things to know about SI-BONE’s iFuse Bedrock Granite Implant System

In May 2022, SI-BONE® launched the iFuse Bedrock Granite® Implant System, intended to provide sacropelvic fixation and sacroiliac joint fusion when connected to compatible pedicle screw systems.

Here are five things to know:

1. iFuse Bedrock Granite was awarded Breakthrough Device Designation (BDD) by the FDA: Adult spinal deformity continues to present itself as a complex clinical issue, with lumbopelvic fixation failure rates reported at 24% 1 resulting from screw breakage, screw loosening, set screw expulsion and rod disassociation, and sacroiliac (SI) joint pain. iFuse Bedrock Granite was designed with these common pelvic fixation device failures in mind and was awarded Breakthrough Device Designation by the FDA. BDD is awarded to devices that provide for more effective treatment or diagnosis of life threatening or irreversibly debilitating diseases or conditions.

2. Centers for Medicare and Medicaid Services (CMS) awarded a New Technology Add-on Payment (NTAP) for the iFuse Bedrock Granite implant: The NTAP is a Medicare program that is intended to compensate hospitals for adopting new, innovative technology and providing Medicare beneficiaries early access to such technologies. NTAP enables additional Medicare fee-for-service payment to hospitals above the standard Medicare Severity Diagnosis-Related Group (MS-DRG) payment amount. iFuse Bedrock Granite was deemed to be eligible based on the following criteria: the technology is considered “new” by CMS’ NTAP program standards and is considered a substantial clinical improvement over available therapies. The NTAP applies only to Medicare inpatients and is effective October 1, 2022, for up to 3 years. Learn more about iFuse Bedrock Granite NTAP.

3. Pelvic fixation can be cost effective in short constructs: iFuse Bedrock Granite has been used for pelvic fixation and SI joint fusion in a substantial number of lumbar fusion procedures with short constructs – defined as lumbar fusion to the pelvis from L2 or below. Under certain assumptions, pelvic fixation accompanied by SI joint fusion in short constructs can be cost effective in the short term in high-risk patients (e.g., high BMI, high pelvic incidence). Link to the published literature here.

4. FDA granted an expanded rod compatibility clearance: At the end of December 2022, the FDA granted clearance for expanded rod compatibility with the iFuse Bedrock Granite implant system. The expanded clearance allows for use of iFuse Bedrock Granite with a wide range of rods that are commonly used within multilevel spine fusion surgeries. Read the Press Release.

5. Two points of pelvic fixation may have protective effects: There has been growing usage of two implants per side at the base of spinal fusion constructs. Utilizing two fusion implants per side, e.g., two iFuse Bedrock Granite implants or an iFuse Bedrock Granite implant paired with a second iFuse fusion implant, is shown in finite element analysis to reduce SI joint motion by ~60%, reduce S1 screw stresses by 48%, and reduce L5-S1 motion by 33%3. Clinical studies evaluating the value of two points of fixation across the SI joint during multi-level spinal fusion surgery are in process.


1 Eastlack RK et al.; International Spine Study Group. Rates of Loosening, Failure, and Revision of Iliac Fixation in Adult Deformity Surgery. Spine (Phila Pa 1976). 2022 Jul

2 Ackerman SJ, Deol GS, Polly DW. Cost-Utility Analysis of Sacroiliac Joint Fusion in High-Risk Patients Undergoing Multi-Level Lumbar Fusion to the Sacrum. Clinicoecon Outcomes Res. 2022 Aug 8

3 SI-BONE Technical Study 300949-TS-B | Manuscript currently under review by peer-reviewed journal

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