Cleared Traditional

Athena Cervical Plate System (K180022) - FDA 510(k) Clearance

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

K180022 · Medyssey USA, Inc. · Orthopedic device
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Jul 2018
Decision
198d
Days
Class 2
Risk

K180022 is an FDA 510(k) clearance for the Athena 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 July 20, 2018 after a review of 198 days - an extended review 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: 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 Medyssey USA, Inc. devices

Submission Details

510(k) Number K180022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2018
Decision Date July 20, 2018
Days to Decision 198 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
76d slower than avg
Panel avg: 122d · This submission: 198d
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 244
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K180022.
Cure™ OPEL-C Plate System
K181543 · Meditech Spine, LLC · Aug 2018
Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)
K181549 · Curiteva, LLC · Aug 2018
Curiteva Anterior Cervical Plate System
K181562 · Curiteva, LLC · Aug 2018
Kestrel™ Buttress Plate System
K181063 · Innovasis, Inc. · Jul 2018
Zavation Cervical Plate System
K181244 · Zavation Medical Products, LLC · Jul 2018
Vail ALIF Buttress Plate System
K180755 · Evolution Spine, LLC · Jul 2018