Cleared Traditional

K190415 - ATLAS Plating System

K190415 is the FDA 510(k) clearance for ATLAS Plating System by MiRus, LLC. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K190415 · MiRus, LLC · Orthopedic device
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Apr 2019
Decision
57d
Days
Class 2
Risk

K190415 is an FDA 510(k) clearance for the ATLAS Plating System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on April 19, 2019 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 MiRus, LLC devices

Submission Details

510(k) Number K190415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2019
Decision Date April 19, 2019
Days to Decision 57 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 122d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 Peers - HRS Plate, Fixation, Bone

All 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K190415.
PROSTEP TBC Implant System
K183620 · Wrightmedicaltechnologyinc · Jun 2019
ORTHOLOC™ 2 Lapidus with Rotation System
K190670 · Wrightmedicaltechnologyinc · May 2019
MatrixRIB Fixation System
K190409 · DePuy Synthes · May 2019
Baby Gorilla/Gorilla Plating System
K190365 · Paragon 28, Inc. · Apr 2019
MIS Bunion Plating System
K190658 · Crossroads Extremity Systems, LLC · Apr 2019
EVOS Small Fragment Upper Extremity Plates Line Additions
K190253 · Smith & Nephew, Inc. · Mar 2019