Cleared Traditional

K181818 - Scarlet AL-T

K181818 is the FDA 510(k) clearance for Scarlet AL-T by Spineart. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K181818 · Spineart · Orthopedic device
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Oct 2018
Decision
92d
Days
Class 2
Risk

K181818 is an FDA 510(k) clearance for the Scarlet AL-T. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Spineart (Plan Les Ouates, CH). The FDA issued a Cleared decision on October 9, 2018 after a review of 92 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.

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Submission Details

510(k) Number K181818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2018
Decision Date October 09, 2018
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 K181818.
Reliance Lumbar IBF System
K181118 · Reliance Medical Systems · Jan 2019
Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
K182007 · Renovis Surgical Technologies · Dec 2018
Arco™-SA Lumbar Cage System
K182195 · Neurostructures, Inc. · Nov 2018
DYNA-LINK ELITE Stand-Alone Anterior Lumbar System
K180215 · Life Spine, Inc. · Sep 2018
NuVasive Brigade Lateral System
K181386 · Nu Vasive, Incorporated · Aug 2018
CoreLink® M3™ Stand-Alone Anterior Lumbar System
K180814 · Corelink, LLC · Aug 2018