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510(k) K253488

iFuse INTRA Ti™ Implant System by SI-BONE, Inc. — Product Code OUR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2026
Date Received
October 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sacroiliac Joint Fixation
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

sacroiliac joint fusion

Other clearances by SI-BONE, Inc.

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  • K231689 — iFuse TORQ® Implant System (June 30, 2023)
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  • K222605 — iFuse TORQ® Implant System (September 29, 2022)
  • K213667 — iFuse-TORQ® Implant System (June 10, 2022)

Other clearances for product code OUR

  • K253611 — Falco Fusion System (January 29, 2026)
  • K252834 — Sacroiliac Joint Truss System (SJTS) (January 28, 2026)
  • K251365 — OptumSI Implant System (November 20, 2025)
  • K252322 — SIros-X System (October 22, 2025)
  • K253094 — iFuse Bedrock Granite Implant System (October 9, 2025)
  • K250894 — Eminent Spine Posterior SI System (October 7, 2025)
  • K250647 — SImmetry+ System (July 29, 2025)
  • K250247 — panaSIa SI Fusion System (July 9, 2025)
  • K251395 — The Rialto™ SI Fusion System (June 26, 2025)
  • K242431 — Omnia Medical PsiF DNA™ System (June 6, 2025)