Cleared Traditional

K163446 - AxoGen Nerve Cap

K163446 is an FDA 510(k) clearance for AxoGen Nerve Cap, manufactured by Axogen Corporation. The device is a Class 2 Neurology device with product code JXI cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K163446 · Axogen Corporation · Neurology device
Download Printable Device Report (PDF)
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Aug 2017
Decision
243d
Days
Class 2
Risk

K163446 is an FDA 510(k) clearance for the AxoGen Nerve Cap. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Axogen Corporation (Alachua, US). The FDA issued a Cleared decision on August 8, 2017 after a review of 243 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5275 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Axogen Corporation devices

FDA 510(k) Submission Details - K163446

510(k) Number K163446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2016
Decision Date August 08, 2017
Days to Decision 243 days
Submission Type Traditional
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
94d slower than avg
Panel avg: 149d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

New South Regulatory, LLC
Wendy Perreault

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 - JXI Cuff, Nerve

All 38
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K163446.
VersaWrap Nerve Protector
K201631 · Alafair Biosciences, Inc. · Sep 2020
NeuroShield
K190246 · Monarch Bioimplants GmbH · May 2019
Reaxon Plus
K180222 · Medovent GmbH · Apr 2018
Reinforced Flexible Collagen Nerve Cuff
K170656 · Collagen Matrix, Inc. · Jun 2017
NeuraGen 3D Nerve Guide Matrix
K163457 · Integra LifeSciences Corporation · Jan 2017
AxoGuard Nerve Connector
K162741 · Cook Biotech Incorporated · Oct 2016