Cleared Traditional

K011406 - SPINAL MESH SYSTEM

K011406 is the FDA 510(k) clearance for SPINAL MESH SYSTEM by Medtronic Sofamor Danek, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K011406 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Dec 2001
Decision
233d
Days
Class 2
Risk

K011406 is an FDA 510(k) clearance for the SPINAL MESH SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on December 27, 2001 after a review of 233 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Sofamor Danek, Inc. devices

Submission Details

510(k) Number K011406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2001
Decision Date December 27, 2001
Days to Decision 233 days
Submission Type Traditional
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
111d slower than avg
Panel avg: 122d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K011406.
MODIFICATION TO GEO STRUCTURE
K020048 · Interpore Cross Intl. · Feb 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K010378 · Implex Corp. · Jan 2002
MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131
K014145 · Interpore Cross Intl. · Jan 2002
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131
K010989 · Interpore Cross Intl. · Nov 2001
MODIFICATION TO: STACKABLE CAGE SYSTEM
K013382 · Depuyacromed · Nov 2001
LIFT VB SPINAL SYSTEM
K010930 · Medtronic Sofamor Danek, Inc. · Oct 2001