Cleared Traditional

EVOS Lumbar Interbody System (K150321) - FDA 510(k) Clearance

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

K150321 · Cutting Edge Spine, LLC · Orthopedic device
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Jul 2015
Decision
154d
Days
Class 2
Risk

K150321 is an FDA 510(k) clearance for the EVOS Lumbar Interbody 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 Cutting Edge Spine, LLC (Waxhaw, US). The FDA issued a Cleared decision on July 13, 2015 after a review of 154 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 Cutting Edge Spine, LLC devices

Submission Details

510(k) Number K150321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2015
Decision Date July 13, 2015
Days to Decision 154 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
32d slower than avg
Panel avg: 122d · This submission: 154d
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 465
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K150321.
NuVasive CoRoent Lumbar System
K151472 · Nu Vasive, Incorporated · Sep 2015
CAPSTONE Spinal System, CLYDESDALE Spinal System
K151128 · Medtronic Sofamor Danek USA, Inc. · Aug 2015
NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System
K151374 · Nu Vasive, Incorporated · Aug 2015
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