Cleared Traditional

K193554 - APTUS Forearm Shaft Plates and APTUS Wr...

K193554 is the FDA 510(k) clearance for APTUS Forearm Shaft Plates and APTUS Wr... by Medartis AG. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K193554 · Medartis AG · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2020
Decision
58d
Days
Class 2
Risk

K193554 is an FDA 510(k) clearance for the APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 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 February 16, 2020 after a review of 58 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 Medartis AG devices

Submission Details

510(k) Number K193554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2019
Decision Date February 16, 2020
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 K193554.
Park's Pectus System
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ARIX Ankle System
K193616 · Jeil Medical Corporation · Mar 2020
Pitkar Locked Plating System
K192619 · S.H.Pitkar Orthotools Pvt. , Ltd. · Feb 2020
Comus Locking Plate systems
K190842 · Jiangsu Trauhui Medical Instrument Co., Ltd. · Feb 2020
APTUS Clavicle System
K192984 · Medartis AG · Jan 2020
Tyber Medical Anatomical Plating System
K193222 · Tyber Medical, LLC · Jan 2020