Cleared Special

K043053 - MODIFICATION TO CD HORIZON SPINAL SYSTEM

K043053 is an FDA 510(k) clearance for MODIFICATION TO CD HORIZON SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 157-day FDA review.

K043053 · Medtronic Sofamor Danek · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
157d
Days
Class 2
Risk

K043053 is an FDA 510(k) clearance for the MODIFICATION TO CD HORIZON SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on April 11, 2005 after a review of 157 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 - K043053

510(k) Number K043053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2004
Decision Date April 11, 2005
Days to Decision 157 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
35d slower than avg
Panel avg: 122d · This submission: 157d
Pathway characteristics
Modification to existing cleared device.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 429
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K043053.
ZODIAC SPINAL FIXATION SYSTEM
K050830 · Alphatec/Nexmed · Jun 2005
CD HORIZON SPINAL SYSTEM
K050809 · Medtronic Sofamor Danek USA, Inc. · Jun 2005
BASIS SPINAL SYSTEM
K050484 · Medtronic Sofamor Danek, Inc. · May 2005
TECHTONIX SYSTEM
K050189 · Stryker Spine · Feb 2005
CD HORIZON SPINAL SYSTEM
K050079 · Medtronic Sofamor Danek USA, Inc. · Feb 2005
ISSYS PEDICLE SCREW SYSTEM
K043522 · Custom Spine, Inc. · Jan 2005
K043053 · MODIFICATION TO CD HORIZON SPINAL SYSTEM
Download PDF FDA Summary Medtronic Sofamor Dan…