Cleared Traditional

AEON-C Stand Alone System (K191477) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191477 · Huvexel Co. , Ltd. · Orthopedic device
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Nov 2019
Decision
162d
Days
Class 2
Risk

K191477 is an FDA 510(k) clearance for the AEON-C Stand Alone System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Huvexel Co. , Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on November 13, 2019 after a review of 162 days - an extended review cycle.

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 Huvexel Co. , Ltd. devices

Submission Details

510(k) Number K191477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2019
Decision Date November 13, 2019
Days to Decision 162 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
40d slower than avg
Panel avg: 122d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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

Dio Medical Corporation
Milan George

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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 93
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K191477.
Mecta-C Stand Alone
K192906 · Medacta International S.A. · Mar 2020
Atlas Spine Expandable Cervical Standalone Interbody System
K192570 · Atlas Spine, Inc. · Feb 2020
Genesys Spine 3DP Cervical Interbody System
K191489 · Genesys Spine · Jan 2020
NuVasive CoRoent Small Interlock System
K192582 · Nu Vasive, Incorporated · Nov 2019
Cervical Spinal Truss System-Stand Alone (CSTS-SA)
K190870 · 4Web, Inc. · Aug 2019
Elevation Spine Saber-C System
K190885 · Elevation Spine · Aug 2019