Cleared Special

K253094 - iFuse Bedrock Granite Implant System

K253094 is an FDA 510(k) clearance for iFuse Bedrock Granite Implant System, manufactured by SI-BONE, Inc.. The device is a Class 2 Orthopedic device with product code OUR cleared through the Special 510(k) pathway after a 16-day FDA review.

K253094 · SI-BONE, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
16d
Days
Class 2
Risk

K253094 is an FDA 510(k) clearance for the iFuse Bedrock Granite Implant System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by SI-BONE, Inc. (Santa Clara, US). The FDA issued a Cleared decision on October 9, 2025 after a review of 16 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K253094

510(k) Number K253094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2025
Decision Date October 09, 2025
Days to Decision 16 days
Submission Type Special
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
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

OUR Device Classification - Class 2, Special Controls

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 132
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K253094.
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
Eminent Spine Posterior SI System
K250894 · Eminent Spine · Oct 2025
SImmetry+ System
K250647 · Sivantage · Jul 2025
panaSIa SI Fusion System
K250247 · Wenzel Spine, Inc. · Jul 2025
K253094 · iFuse Bedrock Granite Implant System
Download PDF FDA Summary SI-BONE, Inc.