Cleared Traditional

K014296 - CD HORIZON SPINAL SYSTEM

K014296 is an FDA 510(k) clearance for CD HORIZON SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K014296

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.

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 382
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