Cleared Special

K093434 - VERTEX RECONSTRUCTION SYSTEM AND VERTEX...

K093434 is the FDA 510(k) clearance for VERTEX RECONSTRUCTION SYSTEM AND VERTEX... by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 28-day FDA review.

K093434 · Medtronic Sofamor Danek · Orthopedic device
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Dec 2009
Decision
28d
Days
Class 2
Risk

K093434 is an FDA 510(k) clearance for the VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on December 2, 2009 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Medtronic Sofamor Danek devices

Submission Details

510(k) Number K093434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2009
Decision Date December 02, 2009
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To 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 - NKB Thoracolumbosacral Pedicle Screw System

All 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K093434.
SYNTHES MATRIX SYSTEM
K092929 · Synthes (Usa) · Dec 2009
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K092325 · Medtronic Sofamor Danek USA, Inc. · Dec 2009
XIA 4.5 SPINAL SYSTEM
K092605 · Stryker Spine · Dec 2009
EXPEDIUM SPINE SYSTEM
K092473 · Depuy Spine, Inc. · Nov 2009
CLAMPFIX
K090605 · Synthes (Usa) · Nov 2009
TSRH SPINAL SYSTEM
K093058 · Medtronic Sofamor Danek, Inc. · Oct 2009