Cleared Traditional

K113529 - CD HORIZON VOYAGER SPINAL SYSTEM

K113529 is the FDA 510(k) clearance for CD HORIZON VOYAGER SPINAL SYSTEM by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K113529 · Medtronic Sofamor Danek · Orthopedic device
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Feb 2012
Decision
71d
Days
Class 2
Risk

K113529 is an FDA 510(k) clearance for the CD HORIZON VOYAGER SPINAL SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on February 9, 2012 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Sofamor Danek devices

Submission Details

510(k) Number K113529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 30, 2011
Decision Date February 09, 2012
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K113529.
POWER ADAPTOR INSTRUMENT ACCESSORY
K120434 · Stryker Corp. · Mar 2012
ICON (TM) MODULAR PEDICLE SCREW SYSTEM
K111448 · Orthofix, Inc. · Feb 2012
FOCUS SPINAL SYSTEM
K120140 · L & K Biomed Co., Ltd. · Feb 2012
DEPUY PULSE THORACOLUMBAR SCREW SYSTEM
K113396 · Medos International SARL · Feb 2012
XENON(TM) PEDICLE SCREW SYSTEM
K111634 · Alphatec Spine, Inc. · Jan 2012
FOCUS MIS SYSTEM
K112643 · L & K Biomed Co., Ltd. · Jan 2012