Cleared Traditional

COROENT SYSTEM (K141896) - FDA 510(k) Clearance

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

K141896 · Nu Vasive, Incorporated · Orthopedic device
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Nov 2014
Decision
129d
Days
Class 2
Risk

K141896 is an FDA 510(k) clearance for the COROENT SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on November 20, 2014 after a review of 129 days - within the typical 510(k) review window.

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 Nu Vasive, Incorporated devices

Submission Details

510(k) Number K141896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2014
Decision Date November 20, 2014
Days to Decision 129 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
7d slower than avg
Panel avg: 122d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 433
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K141896.
DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
K150135 · Medtronic Sofamor Danek USA, Inc. · Jun 2015
ELEVATE Spinal System
K142559 · Medtronic Sofamor Danek USA, Inc. · Jun 2015
The Octane Straight Intervertebral Fusion Device, Ti Coated
K150152 · Exactech, Inc. · May 2015
CLYDESDALE(R) SPINAL SYSTEM
K133577 · Medtronic Sofamor Danek USA, Inc. · Sep 2014
ALTERA SPACER
K140411 · Globus Medical, Inc. · Jul 2014
OCTANE ELEVATE SPINAL IMPLANT SYSTEM
K123607 · Exactech, Inc. · Apr 2014