Cleared Special

K163457 - NeuraGen 3D Nerve Guide Matrix

K163457 is an FDA 510(k) clearance for NeuraGen 3D Nerve Guide Matrix, manufactured by Integra LifeSciences Corporation. The device is a Class 2 Neurology device with product code JXI cleared through the Special 510(k) pathway after a 28-day FDA review.

K163457 · Integra LifeSciences Corporation · Neurology device
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Jan 2017
Decision
28d
Days
Class 2
Risk

K163457 is an FDA 510(k) clearance for the NeuraGen 3D Nerve Guide Matrix. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on January 6, 2017 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5275 - the FDA neurology device 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 Integra LifeSciences Corporation devices

FDA 510(k) Submission Details - K163457

510(k) Number K163457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2016
Decision Date January 06, 2017
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

JXI Device Classification - Class 2, Special Controls

Product Code JXI Cuff, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5275
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 Neurology devices follow this clearance model.

Regulatory Peers - JXI Cuff, Nerve

All 35
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K163457.
Reaxon Plus
K180222 · Medovent GmbH · Apr 2018
AxoGen Nerve Cap
K163446 · Axogen Corporation · Aug 2017
Reinforced Flexible Collagen Nerve Cuff
K170656 · Collagen Matrix, Inc. · Jun 2017
AxoGuard Nerve Connector
K162741 · Cook Biotech Incorporated · Oct 2016
NERBRIDGE
K152967 · Toyobo Co., Ltd. · Jun 2016
Nerve Capping Device
K152684 · Polyganics Innovations BV · Jan 2016