Cleared Special

K241574 - iFuse TORQ Implant System

K241574 is the FDA 510(k) clearance for iFuse TORQ Implant System by SI-BONE, Inc.. It is a Class 2 Orthopedic device (product code OUR) cleared through the Special 510(k) pathway after a 29-day FDA review.

K241574 · SI-BONE, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2024
Decision
29d
Days
Class 2
Risk

K241574 is an FDA 510(k) clearance for the iFuse TORQ® 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 July 2, 2024 after a review of 29 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.

View all SI-BONE, Inc. devices

Submission Details

510(k) Number K241574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2024
Decision Date July 02, 2024
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 104
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K241574.
iFuse TORQ TNT™ Implant System
K241504 · SI-BONE, Inc. · Aug 2024
SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
K241813 · Si-Technology, LLC · Aug 2024
ARx® SAI Implant System
K241464 · Life Spine, Inc. · Jul 2024
Eminent Spine SI Screw System
K240505 · Eminent Spine, LLC · Jun 2024
BowTie™ SI Joint Fusion System
K232149 · Sail Fusion, LLC · Apr 2024
Patriot-SI Posterior Implant System
K232259 · Spinal Simplicity, LLC · Apr 2024