Cleared Special

K160291 - Optimus ALIF System

K160291 is an FDA 510(k) clearance for Optimus ALIF System, manufactured by Amendia, Inc.. The device is a Class 2 Orthopedic device with product code OVD cleared through the Special 510(k) pathway after a 15-day FDA review.

K160291 · Amendia, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
15d
Days
Class 2
Risk

K160291 is an FDA 510(k) clearance for the Optimus ALIF System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Amendia, Inc. (Marietta, US). The FDA issued a Cleared decision on February 18, 2016 after a review of 15 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.

FDA 510(k) Submission Details - K160291

510(k) Number K160291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2016
Decision Date February 18, 2016
Days to Decision 15 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
107d faster than avg
Panel avg: 122d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

OVD Device Classification - Class 2, Special Controls

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar 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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 203
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K160291.
TransContinental® M Spacers and InterContinental® Plate-Spacers
K161223 · Globus Medical, Inc. · Jul 2016
ENZA Zero-Profile Anterior Interbody Fusion
K153720 · Camber Spine Technologies · May 2016
NuVasive® Interfixated Interbody System
K160051 · Nu Vasive, Incorporated · Apr 2016
VerteLP Interbody Fusion Device
K151312 · Vgi, LLC · Jan 2016
Sahara Stabilization System
K151481 · K2m, Inc. · Dec 2015
NuVasive Foundation-LL System
K152943 · Nu Vasive, Incorporated · Dec 2015
K160291 · Optimus ALIF System
Download PDF FDA Summary Amendia, Inc.