Cleared Traditional

K251395 - The Rialto™ SI Fusion System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251395 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2025
Decision
52d
Days
Class 2
Risk

K251395 is an FDA 510(k) clearance for the The Rialto™ SI Fusion System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on June 26, 2025 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K251395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 122d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OUR Sacroiliac Joint Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OUR Sacroiliac Joint Fixation

All 130
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K251395.
CATAMARAN™ SI Joint Fusion System
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K253488 · SI-BONE, Inc. · Feb 2026
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K253611 · Mcnicoll Surgical, Inc. · Jan 2026
Sacroiliac Joint Truss System (SJTS)
K252834 · 4Web Medical · Jan 2026
OptumSI Implant System
K251365 · Si Solutions, LLC · Nov 2025
SIros-X System
K252322 · Genesys Spine · Oct 2025