Cleared Special

K061592 - MODIFICATION TO CD HORIZON SYSTEM

K061592 is the FDA 510(k) clearance for MODIFICATION TO CD HORIZON SYSTEM by Medtronic Sofamor Danek, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 25-day FDA review.

K061592 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Jul 2006
Decision
25d
Days
Class 2
Risk

K061592 is an FDA 510(k) clearance for the MODIFICATION TO CD HORIZON 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, Inc. (Memphis, US). The FDA issued a Cleared decision on July 3, 2006 after a review of 25 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. 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, Inc. devices

Submission Details

510(k) Number K061592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2006
Decision Date July 03, 2006
Days to Decision 25 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
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 K061592.
EBI ARAY SPINAL SYSTEM
K062685 · Ebi, L.P. · Oct 2006
XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM
K061854 · Stryker Spine · Jul 2006
REVERE STABILIZATION SYSTEM
K061202 · Globus Medical, Inc. · Jul 2006
VIPER SPINE SYSTEM
K061520 · Depuy Spine, Inc. · Jun 2006
EBI ARRAY SPINAL SYSTEM
K061563 · Ebi, L.P. · Jun 2006
XIA TITANIUM AND 4.5 SPINAL SYSTEMS
K060979 · Stryker Spine · May 2006