Cleared Traditional

iFuse INTRA Ti? Implant System

K253488 · SI-BONE, Inc. · Orthopedic
Feb 2026
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K253488 is an FDA 510(k) clearance for the iFuse INTRA Ti? Implant System, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by SI-BONE, Inc. (Santa Clara, US). The FDA issued a Cleared decision on February 11, 2026, 110 days after receiving the submission on October 24, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K253488 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2025
Decision Date February 11, 2026
Days to Decision 110 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OUR — Sacroiliac Joint Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion