Cleared Special

K043488 - MODIFICATION TO CD HORIZON SPINAL SYSTEM

K043488 is the FDA 510(k) clearance for MODIFICATION TO CD HORIZON SPINAL SYSTEM by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 94-day FDA review.

K043488 · Medtronic Sofamor Danek · Orthopedic device
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Mar 2005
Decision
94d
Days
Class 2
Risk

K043488 is an FDA 510(k) clearance for the MODIFICATION TO CD HORIZON 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 March 21, 2005 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 888.3070 - 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. 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.

View all Medtronic Sofamor Danek devices

Submission Details

510(k) Number K043488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2004
Decision Date March 21, 2005
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.

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 K043488.
CD HORIZON SPINAL SYSTEM
K051674 · Medtronic Sofamor Danek USA, Inc. · Jul 2005
EXPEDIUM SPINE SYSTEM
K051024 · Depuy Spine, Inc. · Jul 2005
CD HORIZON SPINAL SYSTEM
K050439 · Medtronic Sofamor Danek, Inc. · Mar 2005
MODIFICATION TO TSRH SPINAL SYSTEM
K050282 · Medtronic Sofamor Danek · Feb 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043321 · Medtronic Sofamor Danek · Feb 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K042962 · Medtronic Sofamor Danek · Dec 2004