Cleared Special

TRANS1 AXIAL FIXATON SYSTEM (K073514) - FDA 510(k) Clearance

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

K073514 · Trans1 Incorporated · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
28d
Days
Class 2
Risk

K073514 is an FDA 510(k) clearance for the TRANS1 AXIAL FIXATON SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Trans1 Incorporated (Wilmington, US). The FDA issued a Cleared decision on January 11, 2008 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Trans1 Incorporated devices

Submission Details

510(k) Number K073514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2007
Decision Date January 11, 2008
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 224
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K073514.
TRUSS THORACOLUMBAR PLATE SYSTEM
K092108 · Globus Medical, Inc. · Aug 2009
VIP ANTERIOR CERVICAL PLATE SYSTEM
K081391 · Globus Medical, Inc. · Jul 2008
MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM
K080429 · Medtronic Sofamor Danek USA, Inc. · Apr 2008
PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
K071416 · Medtronic Sofamor Danek USA, Inc. · Nov 2007
MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM
K070775 · Globus Medical, Inc. · Apr 2007
CITADEL ANTERIOR LUMBAR PLATE SYSTEM
K062836 · Globus Medical, Inc. · Dec 2006