Cleared Traditional

K193639 - APTUS® Foot 2.8-3.5 System

K193639 is an FDA 510(k) clearance for APTUS Foot 2.8-3.5 System, manufactured by Medartis AG. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K193639 · Medartis AG · Orthopedic device
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Mar 2020
Decision
90d
Days
Class 2
Risk

K193639 is an FDA 510(k) clearance for the APTUS® Foot 2.8-3.5 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-Stadt, CH). The FDA issued a Cleared decision on March 26, 2020 after a review of 90 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

FDA 510(k) Submission Details - K193639

510(k) Number K193639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2019
Decision Date March 26, 2020
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 1226
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K193639.
CoLink Cfx Plating System
K200762 · In2bones USA, LLC · Apr 2020
ATLAS Plating System
K191867 · MiRus, LLC · Apr 2020
APTUS® Ankle Trauma System 2.8/3.5
K193633 · Medartis AG · Mar 2020
GEO 1st MTP Joint Arthrodesis Plating System
K200108 · Gramercy Extremity Orthopedics, LLC · Mar 2020
FINE Osteotomy around the knee
K193614 · Bodycad Laboratories, Inc. · Mar 2020
Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws
K200043 · Field Orthopaedics Pty, Ltd. · Mar 2020