Cleared Special

K042524 - MODIFICATION TO VERTEX RECONSTRUCTION S...

K042524 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 Special 510(k) pathway after a 21-day FDA review.

K042524 · Medtronic Sofamor Danek · Orthopedic device
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Oct 2004
Decision
21d
Days
Class 2
Risk

K042524 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 October 8, 2004 after a review of 21 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. 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 K042524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2004
Decision Date October 08, 2004
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 K042524.
GLAXY 3.2 SPINAL SYSTEM
K043020 · Medtronic Sofamor Danek · Jan 2005
VERTEX RECONSTRUCTION SYSTEM
K042789 · Medtronic Sofamor Danek · Dec 2004
MODIFICATION TO ALTIUS OCT SYSTEM
K043229 · Interpore Cross Intl. · Dec 2004
EXCELLA-M SPINAL SYSTEM
K042143 · Innovasis, Inc. · Oct 2004
VERTEX RECONSTRUCTION SYSTEM
K042498 · Medtronic Sofamor Danek · Oct 2004
SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM
K042508 · Depuy Spine, Inc. · Oct 2004