Cleared Traditional

K123656 - VERTEX RECONSTRUCTION SYSTEM

K123656 is the FDA 510(k) clearance for VERTEX RECONSTRUCTION SYSTEM by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K123656 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Feb 2013
Decision
89d
Days
Class 2
Risk

K123656 is an FDA 510(k) clearance for the VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on February 25, 2013 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K123656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2012
Decision Date February 25, 2013
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 271
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K123656.
MOUNTAINEER OCT SPINAL SYSTEM
K132332 · Medos International SARL · Aug 2013
VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM
K123906 · Medtronic Sofamor Danek USA, Inc. · Apr 2013
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS
K123783 · Globus Medical, Inc. · Mar 2013
GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES
K121877 · Exactech, Inc. · Feb 2013
SPINEOLOGY SPINOUS PROCESS PLATE
K123232 · Spineology, Inc. · Feb 2013
VERTEX RECONSTRUCTION SYSTEM
K123568 · Medtronic Sofamor Danek USA, Inc. · Dec 2012