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SI-BONE

HQ: Santa Clara, CA source · si-bone.com ↗ · West Coast

FDA-cleared device company Clinical Phase 3

Location: Santa Clara, CA · source · Oct 15, 2026

Profile checked Oct 10, 2026

Keywords: Sacroiliac Joint Disruption Sacroiliac Joint Dysfunction Sacroiliac Joint Pain Degenerative Sacroiliitis Insufficiency Fractures Fragility Fracture Sacroiliac Disorder Sacro Iliac Joint Pain Sacro-iliac Joints Spinal Fusion Deformity of Spine Sacroiliac Dysfunction Scoliosis Lumbar Region Sacral Fracture Osteoporosis SI Joint Pain Degenerative Sacroilitis iFuse Implant System iFuse TORQ TNT Implant System Use of iFuse TORQ iFuse INTRA Ti Implant System iFuse Bedrock Granite Implant System SIJ fusion with iFuse-3D iFuse 3-D in Bedrock Configuration Pelvic CT at 5 years post-op

13Trials (company is sponsor)4FDA records (2 yrs)

Timeline

  1. FDA FDA 510(k) clearance: iFuse Granite Onyx™ Implant System — K262067, Sep 23, 2026. Applicant at approval: SI-BONE, Inc. source ↗
  2. Trial start —: Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes source ↗
  3. Trial start —: Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures source ↗
  4. FDA FDA 510(k) clearance: iFuse INTRA Ti™ Implant System — K253488, Feb 11, 2026. Applicant at approval: SI-BONE, Inc. source ↗
  5. FDA FDA 510(k) clearance: iFuse Bedrock Granite Implant System — K253094, Oct 9, 2025. Applicant at approval: SI-BONE, Inc. source ↗
  6. FDA FDA 510(k) clearance: iGPS Navigation Instruments — K251780, Sep 15, 2025. Applicant at approval: SI-BONE, Inc. source ↗
  7. Trial start —: Innovative Spinopelvic Solutions With Real-World Evidence source ↗
  8. Trial start —: Pelvic Fixation and Fusion During Multilevel Spinal Surgery source ↗
  9. Trial start Phase 4: iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction source ↗
  10. Trial start Not phased (device or behavioral study): Sacral Fracture Fusion/Fixation for Rapid Rehabilitation source ↗
  11. Trial start Not phased (device or behavioral study): SI Joint Stabilization in Long Fusion to the Pelvis source ↗
  12. Trial start Not phased (device or behavioral study): Study of Bone Growth in the Sacroiliac Joint After Minimally Invasive Surgery With Titanium Implants source ↗
  13. Trial start —: LOIS: Long-Term Follow-Up in INSITE/SIFI source ↗
  14. Trial start Not phased (device or behavioral study): iFuse Implant System® Minimally Invasive Arthrodesis source ↗
  15. Trial start Phase 4: Validity and Reliability of Diagnostic Findings of SI Joint Blocking source ↗
  16. Trial start Not phased (device or behavioral study): Investigation of Sacroiliac Fusion Treatment (INSITE) source ↗
  17. Trial start —: Sacroiliac Joint Fusion With iFuse Implant System (SIFI) source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 13

RecordTitlePhaseStatusStartPrimary completion
NCT07530497Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring FracturesNot listedRecruiting2026-082028-02 (estimated)
NCT05870488iFuse TORQ for the Treatment of Sacroiliac Joint DysfunctionPhase 4Active, not recruitingMay 23, 2023Apr 23, 2025 (actual)
NCT07565545Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness OutcomesNot listedNot yet recruiting2026-092028-03 (estimated)
NCT06706908Innovative Spinopelvic Solutions With Real-World EvidenceNot listedActive, not recruitingDec 15, 20242034-12 (estimated)
NCT05640908Pelvic Fixation and Fusion During Multilevel Spinal SurgeryNot listedActive, not recruitingJun 5, 20232027-11 (estimated)
NCT03122899Study of Bone Growth in the Sacroiliac Joint After Minimally Invasive Surgery With Titanium ImplantsNot phased (device or behavioral study)CompletedOct 3, 2017Jun 19, 2024 (actual)
NCT04062630SI Joint Stabilization in Long Fusion to the PelvisNot phased (device or behavioral study)CompletedMay 20, 2020Dec 17, 2024 (actual)
NCT05426356Sacral Fracture Fusion/Fixation for Rapid RehabilitationNot phased (device or behavioral study)TerminatedSep 18, 2022Jun 15, 2024 (actual)
NCT01874236Validity and Reliability of Diagnostic Findings of SI Joint BlockingPhase 4TerminatedApr 22, 2013Sep 30, 2014 (actual)
NCT02270203LOIS: Long-Term Follow-Up in INSITE/SIFINot listedCompleted2014-102019-07 (actual)
NCT01741025iFuse Implant System® Minimally Invasive ArthrodesisNot phased (device or behavioral study)Completed2013-06Dec 15, 2015 (actual)
NCT01681004Investigation of Sacroiliac Fusion Treatment (INSITE)Not phased (device or behavioral study)Completed2012-092015-02 (actual)
NCT01640353Sacroiliac Joint Fusion With iFuse Implant System (SIFI)Not listedCompleted2012-072015-01 (actual)

FDA records (last 2 years)

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