Cleared Special

K043561 - MODIFICATION TO VERTE-STACK SPINAL SYSTEM

K043561 is the FDA 510(k) clearance for MODIFICATION TO VERTE-STACK SPINAL SYSTEM by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code MQP) cleared through the Special 510(k) pathway after a 2-day FDA review.

K043561 · Medtronic Sofamor Danek · Orthopedic device
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Dec 2004
Decision
2d
Days
Class 2
Risk

K043561 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 (Memphis, US). The FDA issued a Cleared decision on December 29, 2004 after a review of 2 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 devices

Submission Details

510(k) Number K043561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2004
Decision Date December 29, 2004
Days to Decision 2 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
120d faster than avg
Panel avg: 122d · This submission: 2d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K043561.
PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)
K043206 · Pioneer Surgical Technology · Jan 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043566 · Medtronic Sofamor Danek · Jan 2005
TITANIUM MESH IMPLANT
K041407 · Interpore Cross Intl. · Dec 2004
EBI CAS SPINE SPACER SYSTEM
K042268 · Ebi, L.P. · Oct 2004
SYNTHES CONTOURED SYNMESH SPACER
K041389 · Synthes Spine · Oct 2004
MODIFICATION TO VBR SPINAL SYSTEM
K041722 · Depuy Spine, Inc. · Sep 2004