Cleared Special

K222605 - iFuse TORQ Implant System

K222605 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 31-day FDA review.

K222605 · SI-BONE, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
31d
Days
Class 2
Risk

K222605 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 September 29, 2022 after a review of 31 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 K222605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2022
Decision Date September 29, 2022
Days to Decision 31 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
91d faster than avg
Panel avg: 122d · This submission: 31d
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 105
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K222605.
CASSATT™ SIJ Fixation System
K211785 · Ctl Medical Corporation · Oct 2022
UNITY Sacroiliac Joint Fixation System
K222448 · Dio Medical Corporation · Oct 2022
SILO TFX MIS Sacroiliac Joint Fixation System
K221047 · Aurora Spine, Inc. · Oct 2022
Integrity-SI Fusion System
K222512 · OsteoCentric Technologies · Sep 2022
Camber Sacroiliac (SI) Fixation System
K203503 · Camber Spine Technologies, LLC · Sep 2022
TransLoc 3D
K211496 · Foundation Fusion Solutions, LLC (Dba Cornerloc) · Jul 2022