Cleared Special

T-FIX™ 3DSI Joint Fusion System (K230689) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K230689 · Cutting Edge Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
23d
Days
Class 2
Risk

K230689 is an FDA 510(k) clearance for the T-FIX™ 3DSI Joint Fusion System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Cutting Edge Spine, LLC (Mineral Springs, US). The FDA issued a Cleared decision on April 5, 2023 after a review of 23 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 Cutting Edge Spine, LLC devices

Submission Details

510(k) Number K230689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2023
Decision Date April 05, 2023
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
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 99
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K230689.
iFuse TORQ® Implant System
K231689 · SI-BONE, Inc. · Jun 2023
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K220274 · Anjali Investments L.L.C · Apr 2023
SiJoin®T3
K213815 · Vgi Medical, Inc. · Mar 2023
Entasis 3D Dual-Lead Sacroiliac Implant System
K223708 · Corelink, LLC · Mar 2023
ZESPIN SI Joint Fusion System
K223521 · Aegis Spine, Inc. · Jan 2023