Cleared Special

Xenco Medical Cervical Interbody System (Argus) (K152302) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K152302 · Xenco Medical, LLC · Orthopedic device
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Sep 2015
Decision
27d
Days
Class 2
Risk

K152302 is an FDA 510(k) clearance for the Xenco Medical Cervical Interbody System (Argus). Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Xenco Medical, LLC (San Diego, US). The FDA issued a Cleared decision on September 10, 2015 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Xenco Medical, LLC devices

Submission Details

510(k) Number K152302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2015
Decision Date September 10, 2015
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 183
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K152302.
ANATOMIC PEEK PTC Cervical Fusion System
K160528 · Medtronic Sofamor Danek USA, Inc. · Mar 2016
PERIMETER C (Titanium) Spinal System
K153438 · Medtronic Sofamor Danek USA, Inc. · Mar 2016
CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device
K153373 · Medtronic Sofamor Danek · Jan 2016
NuVasive CoRoent Small Interbody System
K150362 · Nu Vasive, Incorporated · Jun 2015
Ascendant TM Cervical Spacer System
K150130 · Exactech, Inc. · May 2015
Coalition AGX Plate and Coalition AGX Spacer
K142218 · Globus Medical, Inc. · Mar 2015