DeviceClearance

iFuse INTRA Ti Implant System— 510(k) K253488

Substantially Equivalent

SI-BONE, Inc.

FDA 510(k) clearance K253488 for iFuse INTRA Ti Implant System, Substantially Equivalent on 2026-02-11. Applicant: SI-BONE, Inc.. Device class: 2.

Summary

SI-BONE's iFuse INTRA Ti Implant System is filed under product code OUR, sacroiliac joint fixation. The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).

SI-BONE filed from Santa Clara, California. FDA found it substantially equivalent 110 calendar days after receipt (October 24, 2025 to February 11, 2026).

Clearance details

Applicant
SI-BONE, Inc.
Product code
Product code OUR
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Clara, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OUR

product code OUR
Death
3
Injury
347
Total
350

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.