Cleared Special

K151020 - Rampart-T Interbody Fusion System

K151020 is an FDA 510(k) clearance for Rampart-T Interbody Fusion System, manufactured by Spineology, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 97-day FDA review.

K151020 · Spineology, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
97d
Days
Class 2
Risk

K151020 is an FDA 510(k) clearance for the Rampart-T Interbody Fusion 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 Spineology, Inc. (St. Paul, US). The FDA issued a Cleared decision on July 22, 2015 after a review of 97 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K151020

510(k) Number K151020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2015
Decision Date July 22, 2015
Days to Decision 97 days
Submission Type Special
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
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

MAX Device Classification - Class 2, Special Controls

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 898
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K151020.
NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System
K151374 · Nu Vasive, Incorporated · Aug 2015
Biomet Spine Fusion System
K151483 · Biomet Spine, LLC · Jul 2015
PATHWAY ELIF
K143143 · Custom Spine, Inc. · Jul 2015
PROW FUSION
K151654 · Nlt Spine, Ltd. · Jul 2015
InFill Interbody Fusion Devices
K151184 · Pinnacle Spine Group, LLC · Jul 2015
EVOS Lumbar Interbody System
K150321 · Cutting Edge Spine, LLC · Jul 2015
K151020 · Rampart-T Interbody Fusion System
Download PDF FDA Summary Spineology, Inc.