Cleared Traditional

VerteLP Interbody Fusion Device (K151312) - FDA 510(k) Clearance

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

K151312 · Vgi, LLC · Orthopedic device
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Jan 2016
Decision
240d
Days
Class 2
Risk

K151312 is an FDA 510(k) clearance for the VerteLP Interbody Fusion Device. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Vgi, LLC (St. Petersburg, US). The FDA issued a Cleared decision on January 13, 2016 after a review of 240 days - an extended review cycle.

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

Submission Details

510(k) Number K151312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2015
Decision Date January 13, 2016
Days to Decision 240 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
118d slower than avg
Panel avg: 122d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 107
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K151312.
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K161379 · Globus Medical, Inc. · Sep 2016
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K161223 · Globus Medical, Inc. · Jul 2016
MAGNIFY and MAGNIFY-S Spacers
K142498 · Globus Medical, Inc. · Feb 2015
MONUMENT SPACERS
K132559 · Globus Medical, Inc. · Dec 2013
INDEPENDENCE SPACER
K120101 · Globus Medical, Inc. · Mar 2012