Cleared Traditional

IMPEACE and IMPEACE-Uni Anterior Cervical Plate System (K220379) - FDA 510(k) Clearance

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

K220379 · Medynus, Inc. · Orthopedic device
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Mar 2022
Decision
21d
Days
Class 2
Risk

K220379 is an FDA 510(k) clearance for the IMPEACE and IMPEACE-Uni Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Medynus, Inc. (Irvine, US). The FDA issued a Cleared decision on March 3, 2022 after a review of 21 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 Medynus, Inc. devices

Submission Details

510(k) Number K220379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2022
Decision Date March 03, 2022
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
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

Eerkie Corporation
Jeena Mathai

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 K220379.
BALTEUM - ONE™ Lumbar Plate System
K213820 · Huvexel Co. , Ltd. · Mar 2022
EMERGE Anterior Cervical Plate System
K220275 · Evolution Spine · Mar 2022
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K220147 · U&I Corporation · Feb 2022
3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System
K211712 · Orthofix US, LLC · Feb 2022
Cyclops™ Anterior Cervical Plate System
K213901 · Degen Medical · Jan 2022