Cleared Traditional

K143028 - Azure Anterior Cervical Plate System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K143028 · Orthofix, Inc. · Orthopedic device

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May 2015

Decision

220d

Days

Class 2

Risk

K143028 is an FDA 510(k) clearance for the Azure Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Orthofix, Inc. (Lewisville, US). The FDA issued a Cleared decision on May 29, 2015 after a review of 220 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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. Standard predicate reliance. 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 Orthofix, Inc. devices

Submission Details

510(k) Number	K143028 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 21, 2014
Decision Date	May 29, 2015
Days to Decision	220 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

98d slower than avg

Panel avg: 122d · This submission: 220d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

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.