Cleared Traditional

K171914 - Cortina™ Lumbar Cage System

K171914 is an FDA 510(k) clearance for Cortina Lumbar Cage System, manufactured by Neurostructures, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K171914 · Neurostructures, Inc. · Orthopedic device
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Oct 2017
Decision
121d
Days
Class 2
Risk

K171914 is an FDA 510(k) clearance for the Cortina™ Lumbar Cage 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 Neurostructures, Inc. (Irvine, US). The FDA issued a Cleared decision on October 25, 2017 after a review of 121 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 Neurostructures, Inc. devices

FDA 510(k) Submission Details - K171914

510(k) Number K171914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2017
Decision Date October 25, 2017
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Empirical Testing Corp
Kenneth C. Maxwell

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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 797
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K171914.
IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
K173080 · Huvexel Co. , Ltd. · Oct 2017
NuVasive® Modulus TLIF Interbody System
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SeaSpine Ventura NanoMetalene System
K173022 · SeaSpine Orthopedics Corporation · Oct 2017
Ortus™ Expandable Lumbar Interbody Fusion System
K172334 · Atlas Spine, Inc. · Oct 2017
Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology
K172343 · Rti Surgical, Inc. · Oct 2017
NuVasive® Modulus XLIF Interbody System
K172123 · Nu Vasive, Incorporated · Oct 2017