Cleared Traditional

Athena II Cervical Plate System (K183409) - FDA 510(k) Clearance

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

K183409 · Medyssey USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
63d
Days
Class 2
Risk

K183409 is an FDA 510(k) clearance for the Athena II Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Medyssey USA, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on February 11, 2019 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medyssey USA, Inc. devices

Submission Details

510(k) Number K183409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2018
Decision Date February 11, 2019
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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

Silver Pine Consulting, LLC
Rich Jansen

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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 243
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K183409.
ASSURE® Anterior Cervical Plate System
K183056 · Globus Medical, Inc. · Apr 2019
CastleLoc-P Anterior Cervical Plate System
K190425 · L & K Biomed Co., Ltd. · Mar 2019
SMG Anterior Cervical Plate System
K183073 · Sapphire Medical Group · Feb 2019
Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System
K182885 · Medtronic Sofamor Danek USA, Inc. · Feb 2019
SECULOK™ ACP System
K190053 · U&I Corporation · Feb 2019
Pinehurst Anterior Cervical Plate System
K181190 · Signature Orthopaedics Pty, Ltd. · Jan 2019