Slides
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SI-BONE Corporate Overview November 2026
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The statements in this presentation regarding expectations of future events or results, including SI-BONE’s expectations of continued revenue and procedure growth and financial outlook, are “forward-looking” statements. These forward-looking statements are based on SI-BONE’s current expectations and inherently involve significant risks and uncertainties. These risks include SI-BONE’s ability to introduce and commercialize new products and indications, SI-BONE’s ability to maintain favorable reimbursement for procedures using its products, the impact of any future economic weakness or deterioration in economic conditions as a result of tariffs and retaliation by U.S. trading partners on the ability and desire of patients to undergo elective procedures including those using SI-BONE’s products, SI-BONE’s ability to manage risks to its supply chain, future capital requirements driven by new surgical systems requiring instrument tray and implant inventory investment, and the pace of the re-normalization of the healthcare operating environment including the ability and desire of patients and physicians to undergo and perform procedures using SI-BONE’s products. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these and other risks and uncertainties, many of which are described in SI-BONE’s most recent filings on Form 10-K and Form 10-Q, and SI-BONE’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov), especially under the caption “Risk Factors.” SI-BONE does not undertake any obligation to update forward-looking statements and expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law. 2 Forward-Looking Statements
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Business Update
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Third Quarter 2026: Key Highlights 4 Sustained, Diversified Growth • 14.5% worldwide revenue growth to $55.7 million • 13.9% U.S. revenue growth to $52.8 million • ~20% growth in U.S. procedure volume • 650,000 annual target U.S. procedures Focused Execution, Higher Profitability • 79.3% gross margin • $3.0 million in positive AEBITDA (1) • $5.9 million in positive cash from operations • $0.4 million net cash generated Note: As of November 2, 2026 Note: All comparisons are versus Third Quarter 2025 unless otherwise noted 1. SI-BONE uses Adjusted EBITDA as a proxy for profitability. AEBITDA is a non-GAAP financial measures that excludes from net loss the effects of interest income, interest expense, depreciation and amortization and stock -based compensation. Record 1,770 Active Physicians +240 users New DRGs Effective Oct 1st Up to ~$50,000 increase in reimbursement iFuse Granite Onyx FDA Clearance Third breakthrough device with ~$1.5B TAM
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3Q WW REVENUE ($M) Continued Q3 momentum across revenue and volume 5 3Q US REVENUE ($M) U.S. 3Q PROCEDURE VOLUME Note: As of November 2, 2026 Note: Rounded for presentation purposes $48.7 $55.7 3Q25 3Q26 ~15% $46.4 $52.8 3Q25 3Q26 ~14% 5,290 6,325 3Q25 3Q26 ~20%
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Rising Physician Engagement Driving Procedure Demand 6 U.S. ACTIVE PHYSICIAN BASE 1,530 1,770 3Q25 3Q26 ~16% Nearly six years of double-digit U.S. physician growth every quarter Note: As of November 2, 2026 Note: Rounded for presentation purposes
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Increasing Profitability and Solid Liquidity 7 Note: As of November 2, 2026 SI-BONE uses Adjusted EBITDA as a proxy for profitability. AEBITDA is a non-GAAP financial measures that excludes from net loss the effects of interest income, interest expense, depreciation and amortization and stock-based compensation. Any comparison is to prior year period, unless stated otherwise. Increasing profitability ▪ ~32% increase in AEBITDA Solid liquidity ▪ $146.3 million in cash and equivalents ▪ Positive cash flow from operations in the quarter ADJUSTED EBITDA ($M) $2.3 $5.1 $2.5 $2.8 $3.0 3Q25 4Q25 1Q26 2Q26 3Q26
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8 Reaffirmed 2026 WW Revenue Guidance ($M) Guidance FY26 (Current) Guidance FY26 (Prior) Revenue Revenue growth (y/y) $231.0 - $233.0 million ~15% - 16% (implied) $231.0 - $233.0 million ~15% - 16% (implied) Gross Margin ~79% ~79% Operating Expenses (at mid-point of guidance) ~10.5% ~12.0% Note: As of November 2, 2026 $138.9 $167.2 $200.9 $231.0 - $233.0 2023 2024 2025 2026
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9 Differentiated Portfolio Complemented By Strong Fundamentals Robust Data Reimbursement Advantage Strong Execution Track Record Large, Underpenetrated Markets Nearly 200 published papers 4 Randomized Controlled Trials New DRG for iFuse Granite effective October 1st 2026 Filed NTAP application of iFuse Granite Onyx Nearly 6 Years of double-digit U.S. active physician base growth Third Breakthrough Device iFuse Granite Onyx launched in September 2026 $1.5 billion in new annual addressable market 650,000 annual target procedures, for a total annual opportunity ~$5 billion Proven Operational Excellence ~1.5x Operating Leverage in the third quarter $5.9M Positive cash flow from operations in the third quarter Note: As of November 2, 2026 Operating leverage defined as revenue growth divided by operating expenses growth ~$5B Opportunity Breakthrough Products Differentiated Health Economics Scalable Infrastructure Strong Liquidity
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Company Overview
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Market Leading Platform For Compromised Bone Procedural Solutions Innovation 3 Breakthrough Designated Devices 107 WW Patents Evidence 4 Randomized Controlled Trials 1-4 ~200 Peer-reviewed Publications 5 Education 1,770 Active US Physicians 6,7 160,000+ Procedures Performed 8 Commercialization 93 Territory Managers 400+ CSS and Agents ~$5B Opportunity Breakthrough Products Differentiated Health Economics Scalable Infrastructure 11 5. si-bone.com/results 6. Physicians who performed a procedure in the quarter. 7. Physicians encompasses surgeons and interventionalists. 8. Procedures worldwide with SI-BONE products since inception of the company. Note: As of November 2, 2026 1. Polly DW, et al. Int J Spine Surg. 2016 Aug 23;10:28. [INSITE 2yr] 2. Dengler J, et al. J Bone Joint Surg Am. 2019;101(5):400-11. [iMIA 2yr] 3. Shannon SF, et al. Injury. 2025 May 31;56(8):112462. [SAFFRON] 4. Polly DW, et al. World Neurosurg. 2024 Jul;187:e15-e27. [SILVIA 2yr]
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Expanding and Reclassifying Our Addressable Market 280,000 SIJD 60,000 Trauma 130,000 Sacropelvic Fixation Existing TAM * Minimally invasive surgeries include SI joint dysfunction and pelvic trauma ** Complex surgeries include sacropelvic fixation and spinal fusion 12 200,000 UIV / LIV 280,000 SIJD 60,000 Trauma 130,000 Sacropelvic Fixation 200,000 UIV / LIV New TAM Onyx 470,000 Procedures 670,000 Procedures + = $2.4B SIJD $1.0B Sacropelvic Existing TAM $1.5B UIV / LIV $2.4B SIJD $1.0B Sacropelvic $1.5B UIV / LIV New TAM Onyx $3.7B Revenue $5.2B Revenue + = 1. Management estimate for existing and potential products in 2026. Total addressable market defined as target case volumex Current ASP. 2. Sources: Jensen M, et al. Magnetic Resonance Imaging of the Lumbar Spine in People Without Back Pain. N Engl J Med. 1994;331:69-116.; Bernard 1987, Schwarzer 1995, Maigne 1996, Irwin 2007,Sembrano 2009.; INSITE RCT data: 5 years in pain and 31% of patients screened were eligible for surgery.; 4. 1.2M therapeutic injections per year with average patient in 5 years of pain = ~280K cases 3. US Fragility FX TAM: 136K Incidence x 40% surgical candidates = 54K; High Energy FX TAM: 6K Pelvic Trauma Surgeries = 6K Source: Management estimates based on internal research; Melton, et al. (1981). Epidemiologic features of pelvic fractures. Clin Orthop Relat Res; Rommens, et al. (2017). Fragility fractures of the pelvis. JBJS; Demetriades, et al. (2002). Pelvic fractures with abdominal injuries. J Am Coll Surg. 4. 130K Pelvic Fixation target procedures; 30K Deformity Procedures (Source: U.S.2020 Wallstreet Report) less Pediatric Procedures (Source: www.hopkinsmedicine.org); 100K degenerative spine procedures: 400K Lumbar Fusion Procedures (Source: 2020 Wallstreet Report); 25% procedures are L4-S1 and L5-S1 (Source: Orthopedic Network News, October 2020). 200K Spinal Fusion target procedures; 150K spinal fusion procedures for patients with compromised bone (Source: ASD – Spinemarket data 2023, iData Research 2024, https://spinehealth.org/bone-health-spine-surgery/), 50K procedures due to 27% revision rates from screw loosening at UIV/LIV (Source: Arena JD, et al. Upper instrumented vertebra pedicle screw loosening following adult spinal deformity surgery: incidence and outcome analysis. J Neurosurg Spine. 2024 Nov 15;42(2):176-184. Odland K, et al. S1 Pedicle Screw Loosening: A Systematic Review and Meta-Analysis of Risk Factors and Outcomes. Int J Spine Surg. 2025 Sep 2;19(4):426-436. $0.3B Trauma $0.3B Trauma Procedures U.S. annual target cases Revenue U.S. annual addressable $
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13 Three Large Unmet Clinical Needs in Spinopelvic Conditions Pelvic Trauma Spinopelvic Fixation 24% Rate of Pelvic Fixation Failure in ASD Surgery19 28% SI Joint Issues Post Spinal fusion20 27% Screw Loosening Rate at the UIV and LIV21,22 SI Joint Dysfunction 15-30% Chronic LBP is SI Joint1-5 ~40% Symptomatic Post Lumbar Fusion6-9 High Burden of Disease10 Older Population Fragility FXs Increasing11-13 78% of Insufficiency FXs treated Non-surgically14 Increased Mortality Risk, Downward Spiral15-18 1. Bernard 1987 2. Schwarzer 1995 3. Maigne 1996 4. Irwin 2007 5. Sembrano 2009 6. Katz 2003 7. Maigne 2005 8. DePalma 2011 9. Liliang 2011 10.Cher 2014 11. Burge 2007 12. Rommens 2021 13. Lyders 2010 14. Medicare ICD-10 Code Search (Jun 2020) 15. Bakker 2018 16. Ramser 2022 17. Briggs 2023 18. Babayev 2000 19. Eastlack 2022 20. Manzetti 2023 21. Arena 2024 22. Odland 2025 17-22% 1-year Mortality UIV 27% loosening PF 24% failure LIV 27% loosening
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Innovation Driven Differentiated Platform iFuse 3D iFuse Market Leader in SI Joint Fusion iFuse TORQ ® iFuse TORQ TNT ® Cutting-Edge Pelvic Fixation & Fusion; and Fragility Fractures Spinopelvic Fixation iFuse Bedrock Granite ® iFuse Granite Onyx Breakthrough Fixation, Fusion, Foundation; for UIV / LIV 14 Higher removal torque vs. pedicle screws5,6 Facilitates osseointegration Bone density-specific thread forms 6x > rotational resistance vs. screws2* 3 RCTs, 140+ Peer-reviewed studies3,7 Promotes osseointegration4* TORQLock reduces toggle EZDrive® decreases surgical steps IntelliHarvest® self-harvests bone iFuse INTRA V INTRA X ® , INTRA Ti Intra-articular Stabilization & Fusion Small surgical profile Intra-articular placement Designed to improve SI joint stability1* SI Joint Dysfunction Pelvic Trauma 1. SI-BONE Technical Study 301310-TS. 2. SI-BONE Technical Study 300610-TS. 3. Polly – IJSS 2016; Dengler – JBJS Am 2019; https://si-bone.com/results 4. MacBarb – IJSS 2019 (Part 2). 5. SI-BONE Technical Study 301098-TS. 6. SI-BONE Technical Study 303358-TS. 7. Polly DW, et al. World Neurosurg. 2024 Jul;187:e15-e27. [SILVIA 2yr] * Biomechanical and animal studies not necessarily indicative of human clinical outcomes.
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Patent Protected Differentiated Platform ▪ 107 issued patents: U.S. (50), OUS (57) ▪ iFuse 3D implant patents until Sept 2035 ▪ Triangular cutting tool patents until Mar 2033 ▪ iFuse implant patent until August 2028 3-D TECHNOLOGY Rectilinear profile, longitudinal struts, and struts connecting the longitudinal struts 15 Note: As of November 2, 2026 INSTRUMENT Triangular cutting tools that can be used to place our implants ▪ 52 pending patents: U.S. (34), OUS (18) iFuse Bedrock Granite Inner shank with external distal threads and an outer sleeve with threads, surface growth features, and fenestrations iFuse TORQ Helical threads, porous network of struts disposed between the threads, and the porous height is less than the major thread diameter ▪ iFuse TORQ® implant patent until Feb 2041 ▪ iFuse Bedrock Granite® implant patent until Feb 2039
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Portfolio Overview
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Procedures Non-surgical Management Sacroiliac Joint Dysfunction Treatments 17 MIS SI Joint Fusion Radiofrequency Ablation Therapeutic SI Joint Injections (anesthetic & steroids) External Support (SI Joint Belt) Physical Therapy Medications (NSAIDS, opiates, etc.) Bone Allograft SI Joint Stabilization & Fusion
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18 Competitive Advantages Cortical Piercing Intra-articular placement Single Use Instrument Kit Fenestrations Cutting BladesIntra-articular Placement iFuse Lattice Technology Differentiated Technology iFuse INTRA Ti : Intra-Articular Titanium Implant Access/Reimbursement FDA Cleared: February 2026 Uses Existing CPT Code: 27279
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Large, Adjacent Market 1 Differentiated Technology Competitive Advantages >$300 million Pelvic Trauma opportunity ~120K Sacral Fragility fracture incidence / yr. FuSIon 3D Surface for Osseointegration IntelliHarvest® Technology self harvests host bone TORQLock Threads2 10x rotational resistance on insertion vs. trauma screws 19 iFuse TORQ®: Cutting-Edge Pelvic Fixation and Fusion 1. Based on internal estimates. 2. Internal clinical reports. Data on file.
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20 iFuse Granite Onyx : Vertebral Bone Density-Driven Design Large Market $1.5 billion Adult Spinal Deformity, Compromised Bone opportunity1 and UIV/LIV Revision Opportunity Competitive Advantages Breakthrough Device Designation by the FDA New Technology Add-on Payment (“NTAP”) application filed. If approved, NTAP would be effective October 1, 2027 1. Based on management estimate of total addressable market for iFuse Granite Onyx platform. 2. 510(k) Clearance – K262067 (Sep 2026) Variable Thread Forms & Leads Differentiated Technology FDA Clearance 2 September 2026 Self-grafting fenestrations Lattice surface for osseointegration UIV LIV
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21 iFuse Bedrock Granite®: Fixation. Fusion. Foundation. Large, Adjacent Market ~$1 billion Adult Spinal Deformity and Degenerative Spine pelvic fixation opportunity1 Additional application for 9.5 diameter implant in S1 trajectory and pediatric deformity2 Competitive Advantages Breakthrough Device Designation by the FDA New DRG Family established effective October 1, 2026 1. Based on management estimate of total addressable market for existing and potential products in 2024. 2. 510(k) Clearance – K233508 (Jan 2024) OMNICapture Tulip & Set ScrewMicroporous Lattice Surfaces IntelliHarvest® Cutting Flutes Macroporous Fenestrations Differentiated Technology
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• Through ‘N Through (“TNT”)1 • FDA Breakthrough Device Designation2 • Pelvic fragility fracture fixation • Pelvic-specific 8.7mm diameter • 3D-printed porous lattice surface designed for osseointegration 22 iFuse TORQ TNT®: Pelvic Bone Density-Driven Design 1. The first 3D-printed, porous threaded implant with lengths capable of spanning the posterior pelvis, passing through the ipsilat eral ilium, sacrum, and through the contralateral ilium. 2. The FDA determined iFuse TORQ TNT has the potential to provide more effective fixation of pelvic fragility fractures than the current standard of care, cannula ted screws. FDA Clearance September 2024 CMS FY2026 IPPS New Technology Add-On Payment (“NTAP”) of up to $4,136
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Appendix
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Disclosure 24 Reconciliation of Adjusted EBITDA SI-BONE uses Adjusted EBITDA, a non-GAAP financial measure that excludes from net loss the effects of interest income, interest expense, depreciation, amortization, and stock-based compensation. SI-BONE believes the presentation of Adjusted EBITDA is useful to management because it allows management to more consistently analyze period-to-period financial performance and provides meaningful supplemental information with respect to core operational activities used to evaluate management's performance. SI-BONE also believes the presentation of Adjusted EBITDA is useful to investors and other interested persons as it enables these persons to use this additional information to assess the company’s performance in using this additional metric that management uses to assess the company’s performance. Adjusted EBITDA should be considered supplemental to, and not a substitute for, financial information prepared in accordance with GAAP. Because Adjusted EBITDA excludes the effect of items that increase or decrease the Company's reported results of operations, management strongly encourages investors to review, when they become available, the Company's consolidated financial statements and publicly filed reports in their entirety. The Company's definition of Adjusted EBITDA may differ from similarly titled measures used by others. $ in thousands Three Months Ended September 30, 2026 Three Months Ended September 30, 2025 Net loss $ (3,620) $ (4,566) Interest income (1,348) (1,515) Interest expense 608 670 Depreciation and amortization 1,693 1,486 Stock-based compensation 5,713 6,226 Adjusted EBITDA $ 3,046 $ 2,301
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Disclosure 25 Reconciliation of Free Cash Flow SI-BONE uses Free Cash Flow, a non-GAAP financial measure. Free cash flow is defined as net cash provided by operating activities less purchases of property and equipment. SI-BONE believes the presentation of free cash flow is useful to management because it allows management to more consistently analyze period-to-period financial performance and provides meaningful supplemental information with respect to core operational activities used to evaluate management's performance. SI-BONE also believes the presentation of free cash flow is useful to investors and other interested persons as it enables these persons to use this additional information to assess the company’s performance in using this additional metric that management uses to assess the company’s performance. Free cash flow should be considered supplemental to, and not a substitute for, financial information prepared in accordance with GAAP. Because free cash flow excludes the effect of items that increase or decrease the Company's reported results of operations, management strongly encourages investors to review, when they become available, the Company's consolidated financial statements and publicly filed reports in their entirety. The Company's definition of free cash flow may differ from similarly titled measures used by others. $ in thousands Nine Months Ended September 30, 2026 Nine Months Ended September 30, 2025 Net cash provided by (used in) operating activities $ 4,355 $ (2,403) Less: Purchases of Property and Equipment (8,989) (7,126) Free Cash Flow $ (4,634) $ (9,529)
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The iFuse Implant System® is intended for sacroiliac fusion for the following conditions: • Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. • To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. • Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. The iFuse TORQ® Implant System is indicated for sacroiliac joint fusion for: • Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. • Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures. The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORQ Navigation instruments are intended to be used with the Medtronic® StealthStation® System. The TORQ iGPS instruments and iGPS Drill Bits are compatible with Globus ExcelsiusGPS® Instrument Trackers and intended to be used with the iFuse TORQ Implant System and the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D® Imaging System), which is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. Use of the iGPS instruments is limited to use only with 10.0 mm and 11.5 mm fully threaded iFuse TORQ implants. The iFuse INTRA Ti Implant System is intended for fusion of the sacroiliac joint for sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. The iFuse INTRA X® Allograft is indicated for homologous use. The iFuse INTRA X® Allograft Implant System instruments are indicated for placement of the iFuse INTRA X allograft. The iFuse INTRA V Allograft is intended for homologous use. The iFuse INTRA V Allograft Implant System instruments are intended for placement of the iFuse INTRA V allograft. The iFuse TORQ TNT® Implant System is indicated for fracture fixation of the pelvis, including acute, non-acute, and non-traumatic fractures. The iFuse TORQ TNT Implant System is indicated for sacroiliac joint fusion for sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. The iFuse TORQ TNT Navigation instruments are intended to be used with the iFuse TORQ TNT Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ TNT Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORQ TNT Navigation instruments are intended to be used with the Medtronic® StealthStation® System.
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The iFuse Bedrock Granite ® Implant System is intended for sacroiliac joint fusion in skeletally mature patients for the following conditions: • Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This inclu des conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. • To augment immobilization and stabilization of the sacroiliac joint in patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. • Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint When connected to compatible pedicle screw systems with 5.5 - or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Bedrock Granite Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: • Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patie nt history and radiographic studies • Spondylolisthesis • Trauma (i.e., fracture or dislocation) • Spinal stenosis • Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) • Spinal tumor • Pseudarthrosis • Failed previous fusion When connected to compatible pedicle screw systems with 5.5 - or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Bedrock Granite Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally immature patients as an adjunct to thoracolumbar fu sion for the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, as well as the following conditi ons: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicl e screw fixation is limited to a posterior approach. The iFuse Bedrock Granite Navigation instruments are intended to be used with the iFuse Bedrock Granite Implant System and th e Medtronic StealthStation System to assist the surgeon in precisely locating anatomical structures in iFuse Bedrock Granite Implant System procedures, in which the use of stereotactic surgery may be app ropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconst ruction) and/or an image data -based model of the anatomy. The Granite iGPS instruments and iGPS Drill Bits are compatible with Globus ExcelsiusGPS® Instrument Trackers and intended to be used with the iFuse Bedrock Granite Implant System and the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D ® Imaging System), which is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical in struments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. Use of the iGPS instruments is limited to use only with the 9.5 mm and 10.5 mm iFuse Bedrock Granite implants.
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iFuse Granite Onyx Indications for Use: When connected to compatible pedicle screw systems with 5.0-, 5.5- or 6.0-mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Granite Onyx Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the t reatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: • degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patie nt history and radiographic studies • spondylolisthesis • trauma (i.e., fracture or dislocation) • spinal stenosis • deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) • spinal tumor • pseudarthrosis, and/or • failed previous fusion. When connected to compatible pedicle screw systems with 5.0 - , 5.5- or 6.0- mm posterior rods made from either titanium alloy or cobalt chrome alloys, the iFuse Granite Onyx Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally immature patients as an adjunct to fusion for the t reatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, as well as the following conditions: spond ylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Please refer to the additional information section in the Instructions for Use on compatible pedicle screw system rods. The iFuse Granite Onyx Navigation instruments are intended to be used with the iFuse Granite Onyx Implant System and the Medt ronic StealthStation System to assist the surgeon in precisely locating anatomical structures in iFuse Granite Onyx Implant System procedures, in which the use of stereotactic surgery may be approp riate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruc tion) and/or an image data -based model of the anatomy. The Onyx iGPS instruments are compatible with Globus ExcelsiusGPS® Instrument Trackers and intended to be used with the iFuse Granite Onyx Implant System and the Globus ExcelsiusGPS® Robotic Navigation System (including the Globus Excelsius3D® Imaging System), which is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. For Use for indications, contraindications, warnings, and precautions at si-bone.com/label. There are potential risks associated with iFuse procedures. They may not be appropriate for all patients, and all patients ma y not benefit. For information about the risks, visit si-bone.com/risks.
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11/2/2026 h Pioneering Procedural Solutions For Compromised Bone ® 29 160,000+ Procedures 1,770 Active Physicians ~200 Publications Note: As of November 2, 2026