Cleared Traditional

K014296 - CD HORIZON SPINAL SYSTEM

K014296 is the FDA 510(k) clearance for CD HORIZON SPINAL SYSTEM by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K014296 · Medtronic Sofamor Danek · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
344d
Days
Class 2
Risk

K014296 is an FDA 510(k) clearance for the 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 December 10, 2002 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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. Elevated predicate reliance profile. 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 devices

Submission Details

510(k) Number K014296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2001
Decision Date December 10, 2002
Days to Decision 344 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
222d slower than avg
Panel avg: 122d · This submission: 344d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 271
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K014296.
MOSS MIAMI SPINAL SYSTEM PIN NUT
K023804 · Depuyacromed · Jan 2003
MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM
K023415 · Medtronic Sofamor Danek · Dec 2002
LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
K023797 · Medtronic Sofamor Danek · Dec 2002
INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM
K022048 · Interpore Cross Intl. · Dec 2002
SYNTHES CERVIFIX/ AXON
K023675 · Synthes (Usa) · Nov 2002
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K023555 · Medtronic Sofamor Danek, Inc. · Nov 2002