Cleared Special

K161280 - Cervical Stand Alone System

K161280 is the FDA 510(k) clearance for Cervical Stand Alone System by Orthofix, Inc.. It is a Class 2 Orthopedic device (product code OVE) cleared through the Special 510(k) pathway after a 42-day FDA review.

K161280 · Orthofix, Inc. · Orthopedic device
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Jun 2016
Decision
42d
Days
Class 2
Risk

K161280 is an FDA 510(k) clearance for the Cervical Stand Alone System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Orthofix, Inc. (Lewisville, US). The FDA issued a Cleared decision on June 17, 2016 after a review of 42 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 Orthofix, Inc. devices

Submission Details

510(k) Number K161280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2016
Decision Date June 17, 2016
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation.
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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 114
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K161280.
SeaSpine Shoreline ACS - Anterior Cervical Standalone System
K161081 · SeaSpine Orthopedics Corporation · Sep 2016
Pro-Link® Stand-Alone Cervical Spacer System
K160066 · Life Spine, Inc. · Sep 2016
Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System
K153352 · Spinal Elements, Inc. · Aug 2016
COALITION Spacers
K151939 · Globus Medical, Inc. · Jan 2016
SCARLET® AC-T Secured Anterior Cervical Cage
K143214 · Spineart · Feb 2015
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
K141599 · Medtronic Sofamor Danek USA, Inc. · Jan 2015