Cleared Special

RAMPART-L (K133371) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K133371 · Spineology, Inc. · Orthopedic device
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Jan 2014
Decision
69d
Days
Class 2
Risk

K133371 is an FDA 510(k) clearance for the RAMPART-L. 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 Spineology, Inc. (Saint Paul, US). The FDA issued a Cleared decision on January 9, 2014 after a review of 69 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.

View all Spineology, Inc. devices

Submission Details

510(k) Number K133371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2013
Decision Date January 09, 2014
Days to Decision 69 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

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 435
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K133371.
ALTERA SPACER
K140411 · Globus Medical, Inc. · Jul 2014
OCTANE ELEVATE SPINAL IMPLANT SYSTEM
K123607 · Exactech, Inc. · Apr 2014
CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
K133205 · Medtronic Sofamor Danek USA, Inc. · Mar 2014
PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM
K133645 · Medtronic Sofamor Danek USA, Inc. · Jan 2014
CAPSTONE SPINAL SYSTEM
K133650 · Medtronic Sofamor Danek USA, Inc. · Dec 2013
PERIMETER INTERBODY FUSION DEVICE
K131669 · Medtronic Sofamor Danek USA, Inc. · Nov 2013