Cleared Traditional

K071942 - MODIFICATION TO VERTEX RECONSTRUCTION S...

K071942 is the FDA 510(k) clearance for MODIFICATION TO VERTEX RECONSTRUCTION S... by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K071942 · Medtronic Sofamor Danek · Orthopedic device
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Dec 2007
Decision
151d
Days
Class 2
Risk

K071942 is an FDA 510(k) clearance for the MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on December 11, 2007 after a review of 151 days - an extended review 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: 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 Medtronic Sofamor Danek devices

Submission Details

510(k) Number K071942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2007
Decision Date December 11, 2007
Days to Decision 151 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
29d slower than avg
Panel avg: 122d · This submission: 151d
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 K071942.
BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM
K080394 · Blackstone Medical, Inc. · Mar 2008
BLACKSTONE ASCENT MULTIAXIAL SCREWS
K073420 · Blackstone Medical, Inc. · Feb 2008
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR
K073654 · Blackstone Medical, Inc. · Jan 2008
ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM
K072081 · Alphatec Spine, Inc. · Oct 2007
TRAVERSE OCT SPINAL FIXATION SYSTEM
K062447 · Medtronic Sofamor Danek, Inc. · Oct 2007
MODIFICATION TO OASYS SYSTEM
K072568 · Stryker Spine · Oct 2007