Cleared Special

K041197 - MODIFICATION TO VERTE-STACK SPINAL SYSTEM

K041197 is an FDA 510(k) clearance for MODIFICATION TO VERTE-STACK SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek. The device is a Class 2 Orthopedic device with product code MQP cleared through the Special 510(k) pathway after a 94-day FDA review.

K041197 · Medtronic Sofamor Danek · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
94d
Days
Class 2
Risk

K041197 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 August 9, 2004 after a review of 94 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K041197

510(k) Number K041197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2004
Decision Date August 09, 2004
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
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 279
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K041197.
EXPANDABLE PEEK VBR IMPLANT
K040928 · Interpore Cross Intl. · Aug 2004
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS
K041939 · Blackstone Medical, Inc. · Aug 2004
CURVED PEEK TETRIS SPINAL IMPLANT
K041888 · Signus Medizintechnik GmbH · Aug 2004
STRYKER SPINE VERTEBRAL SPACER
K040731 · Stryker Spine · Aug 2004
HOURGLASS VERTEBRAL BODY SPACER
K033926 · Medtronic Sofamor Danek · Jul 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041556 · Medtronic Sofamor Danek · Jul 2004
K041197 · MODIFICATION TO VERTE-STACK SPINAL SYSTEM
Download PDF FDA Summary Medtronic Sofamor Dan…