Cleared Traditional

K180002 - Rampart One Lumbar Interbody Fusion Device

K180002 is the FDA 510(k) clearance for Rampart One Lumbar Interbody Fusion Device by Spineology, Inc.. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K180002 · Spineology, Inc. · Orthopedic device
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Apr 2018
Decision
113d
Days
Class 2
Risk

K180002 is an FDA 510(k) clearance for the Rampart One Lumbar Interbody Fusion Device. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Spineology, Inc. (Saint Paul, US). The FDA issued a Cleared decision on April 25, 2018 after a review of 113 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 Spineology, Inc. devices

Submission Details

510(k) Number K180002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2018
Decision Date April 25, 2018
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 147
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K180002.
FBC 921 (ALIF)
K180695 · Fbc Device Aps · Jul 2018
S128 Anterior Lumbar Interbody Fusion (ALIF) System
K180502 · Renovis Surgical Technologies, Inc. · Jun 2018
HARRIER-SA™ Lumbar Interbody System
K180519 · Choicespine, LP · May 2018
ENZA-A Titanium ALIF
K173432 · Camber Spine Technologies · Apr 2018
SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device
K173606 · SeaSpine Orthopedics Corporation · Apr 2018
Arco™-SA Lumbar Cage System
K173082 · Neurostructures, Inc. · Mar 2018