Cleared Special

K182195 - Arco-SA Lumbar Cage System

K182195 is the FDA 510(k) clearance for Arco-SA Lumbar Cage System by Neurostructures, Inc.. It is a Class 2 Orthopedic device (product code OVD) cleared through the Special 510(k) pathway after a 87-day FDA review.

K182195 · Neurostructures, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
87d
Days
Class 2
Risk

K182195 is an FDA 510(k) clearance for the Arco™-SA Lumbar Cage System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Neurostructures, Inc. (Irvine, US). The FDA issued a Cleared decision on November 9, 2018 after a review of 87 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 Neurostructures, Inc. devices

Submission Details

510(k) Number K182195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2018
Decision Date November 09, 2018
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Empirical Consulting
Meredith Lee May

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 141
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K182195.
Avenue P Cage System
K181096 · Zimmer Biomet Spine, Inc. · Jan 2019
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
Scarlet AL-T
K181818 · Spineart · Oct 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