Cleared Traditional

K071942 - MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM

K071942 is an FDA 510(k) clearance for MODIFICATION TO VERTEX RECONSTRUCTION S..., manufactured by Medtronic Sofamor Danek. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K071942

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.

KWP Device Classification - Class 2, Special Controls

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 382
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