Cleared Special

K052261 - MODIFICATION TO: VERTE-STACK SPINAL SYSTEM

K052261 is an FDA 510(k) clearance for MODIFICATION TO: VERTE-STACK SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Special 510(k) pathway after a 49-day FDA review.

K052261 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Oct 2005
Decision
49d
Days
Class 2
Risk

K052261 is an FDA 510(k) clearance for the MODIFICATION TO: VERTE-STACK SPINAL SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on October 7, 2005 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 USA, Inc. devices

FDA 510(k) Submission Details - K052261

510(k) Number K052261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2005
Decision Date October 07, 2005
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 259
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K052261.
KIMBA SPINAL IMPLANT
K052533 · Signus Medizintechnik GmbH · Nov 2005
CONCORDE VBR SPINAL SYSTEM
K052746 · Depuy Spine, Inc. · Oct 2005
EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE
K050997 · Flexuspine, Inc. · Oct 2005
LANX VBR SYSTEM
K052384 · Lanx, LLC · Oct 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
K051978 · Implex Corp. · Sep 2005
NUBIC SPINAL IMPLANT
K052096 · Signus Medical, LLC · Aug 2005