Cleared Traditional

K142559 - ELEVATE Spinal System

K142559 is the FDA 510(k) clearance for ELEVATE Spinal System by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K142559 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Jun 2015
Decision
271d
Days
Class 2
Risk

K142559 is an FDA 510(k) clearance for the ELEVATE Spinal 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 Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on June 9, 2015 after a review of 271 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 Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K142559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2014
Decision Date June 09, 2015
Days to Decision 271 days
Submission Type Traditional
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
149d slower than avg
Panel avg: 122d · This submission: 271d
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 609
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K142559.
Px PEEK IBF System
K150500 · Innovasis, Inc. · Jun 2015
DePuy Synthes T-PAL Ti Spacer
K151276 · Synthes USA Products, LLC · Jun 2015
DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
K150135 · Medtronic Sofamor Danek USA, Inc. · Jun 2015
Battalion Universal Spacer System
K143740 · Alphatec Spine, Inc. · May 2015
Lucent
K150061 · Spinal Elements, Inc. · May 2015
The Octane Straight Intervertebral Fusion Device, Ti Coated
K150152 · Exactech, Inc. · May 2015