Cleared Traditional

K214123 - T-FIX 3DSI Joint Fusion System

K214123 is an FDA 510(k) clearance for T-FIX 3DSI Joint Fusion System, manufactured by Cutting Edge Spine, LLC. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K214123 · Cutting Edge Spine, LLC · Orthopedic device
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Jun 2022
Decision
176d
Days
Class 2
Risk

K214123 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 June 24, 2022 after a review of 176 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Cutting Edge Spine, LLC devices

FDA 510(k) Submission Details - K214123

510(k) Number K214123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2021
Decision Date June 24, 2022
Days to Decision 176 days
Submission Type Traditional
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
54d slower than avg
Panel avg: 122d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 119
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K214123.
Camber Sacroiliac (SI) Fixation System
K203503 · Camber Spine Technologies, LLC · Sep 2022
TransLoc 3D
K211496 · Foundation Fusion Solutions, LLC (Dba Cornerloc) · Jul 2022
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System
K221050 · Aegis Spine, Inc. · Jun 2022
iFuse-TORQ® Implant System
K213667 · SI-BONE, Inc. · Jun 2022
iFuse Bedrock Granite™ Implant System
K220195 · SI-BONE, Inc. · May 2022
TRELLIS™ SI Joint Fusion System
K212962 · Orthofundamentals, LLC · Apr 2022