Cleared Special

K222605 - iFuse TORQ® Implant System

K222605 is an FDA 510(k) clearance for iFuse TORQ 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 31-day FDA review.

K222605 · SI-BONE, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K222605

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.

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 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
K222605 · iFuse TORQ® Implant System
Download PDF FDA Summary SI-BONE, Inc.