Cleared Traditional

K181009 - APTUS CMC-I Fusion Plate System

K181009 is the FDA 510(k) clearance for APTUS CMC-I Fusion Plate System by Medartis AG. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K181009 · Medartis AG · Orthopedic device
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Aug 2018
Decision
129d
Days
Class 2
Risk

K181009 is an FDA 510(k) clearance for the APTUS CMC-I Fusion Plate 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 Medartis AG (Basel, CH). The FDA issued a Cleared decision on August 24, 2018 after a review of 129 days - within the typical 510(k) review window.

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: 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 Medartis AG devices

Submission Details

510(k) Number K181009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2018
Decision Date August 24, 2018
Days to Decision 129 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
7d slower than avg
Panel avg: 122d · This submission: 129d
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 Consultant

PaxMed International, LLC
Kevin A. Thomas

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 - HRS Plate, Fixation, Bone

All 914
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K181009.
ARIX Clavicle System
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CoLink View Plating System
K182402 · In2bones USA, LLC · Sep 2018
Tandry Locking Plate System
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AOS Small Fragment Plating System Lite
K181035 · Advanced Orthopaedic Solutions, Inc. (Aos) · Aug 2018
EVOS Wrist Fracture Plating System
K181533 · Smith & Nephew, Inc. · Aug 2018
APTUS® Proximal Humerus System
K181425 · Medartis AG · Aug 2018