Cleared Traditional

The Rialto? SI Fusion System

K251395 · Medtronic Sofamor Danek USA, Inc. · Orthopedic
Jun 2025
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K251395 is an FDA 510(k) clearance for the The Rialto? SI Fusion System, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on June 26, 2025, 52 days after receiving the submission on May 5, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K251395 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2025
Decision Date June 26, 2025
Days to Decision 52 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