Cleared Special

K052376 - MODIFICATION TO: VERTEX RECONSTRUCTION ...

K052376 is the FDA 510(k) clearance for MODIFICATION TO: VERTEX RECONSTRUCTION ... by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code KWP) cleared through the Special 510(k) pathway after a 24-day FDA review.

K052376 · Medtronic Sofamor Danek · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
24d
Days
Class 2
Risk

K052376 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 September 23, 2005 after a review of 24 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 K052376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2005
Decision Date September 23, 2005
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 K052376.
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052734 · Medtronic Sofamor Danek · Oct 2005
EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS
K052131 · Depuy Spine, Inc. · Sep 2005
SYNTHES PANGEA SYSTEM
K052123 · Synthes (Usa) · Sep 2005
VERTEX RECONSTRUCTION SYSTEM
K052402 · Medtronic Sofamor Danek · Sep 2005
MODIFICATION TO XIA SPINAL SYSTEM
K052181 · Stryker Spine · Sep 2005
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K052180 · Medtronic Sofamor Danek · Aug 2005