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)
Optimized for regulatory review, auditing and printing
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
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 148d · 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 Peers - JXI Cuff, Nerve

All 27
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
NEURAGEN 3D
K130557 · Integra LifeSciences Corporation · Apr 2014