Cleared Special

K042235 - ORION ANTERIOR CERVICAL PLATING SYSTEM

K042235 is the FDA 510(k) clearance for ORION ANTERIOR CERVICAL PLATING SYSTEM by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 30-day FDA review.

K042235 · Medtronic Sofamor Danek · Orthopedic device
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Sep 2004
Decision
30d
Days
Class 2
Risk

K042235 is an FDA 510(k) clearance for the ORION ANTERIOR CERVICAL PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on September 17, 2004 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 devices

Submission Details

510(k) Number K042235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2004
Decision Date September 17, 2004
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K042235.
VENTURE ANTERIOR CERVICAL PLATING SYSTEM
K042922 · Medtronic Sofamor Danek, Inc. · Nov 2004
C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM
K042798 · Interpore Cross Intl. · Nov 2004
ORION ANTERIOR CERVICAL PLATING SYSTEM
K042499 · Medtronic Sofamor Danek · Oct 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K042025 · Medtronic Sofamor Danek, Inc. · Aug 2004
EXPEDIUM ANTERIOR SPINE SYSTEM
K041205 · Depuy Spine, Inc. · Aug 2004
NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM
K041447 · Nuvasive, Inc. · Aug 2004