Cleared Traditional

K160702 - ZION Anterior Cervical Fixation System

K160702 is the FDA 510(k) clearance for ZION Anterior Cervical Fixation System by Astura Medical. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K160702 · Astura Medical · Orthopedic device
Download Printable Device Report (PDF)
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Aug 2016
Decision
162d
Days
Class 2
Risk

K160702 is an FDA 510(k) clearance for the ZION Anterior Cervical Fixation System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Astura Medical (Carlsbad, US). The FDA issued a Cleared decision on August 23, 2016 after a review of 162 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 Astura Medical devices

Submission Details

510(k) Number K160702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2016
Decision Date August 23, 2016
Days to Decision 162 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
40d slower than avg
Panel avg: 122d · This submission: 162d
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.

Regulatory Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 433
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K160702.
LOSPA IS ACP System
K161641 · Corentec Co., Ltd. · Jan 2017
CETRA Anterior Cervical Plate System
K162638 · Orthofix, Inc. · Dec 2016
Pyrenees Cervical Plate System
K162664 · K2m, Inc. · Oct 2016
TRYPTIK2C-plate Anterior Cervical Plate System
K153042 · Spineart · Mar 2016
Cam Lock Plating System
K152282 · Life Spine, Inc. · Nov 2015
ATLANTIS Anterior Cervical Plate System
K152623 · Medtronic Sofamor Danek USA, Inc. · Nov 2015