Cleared Traditional

K243610 - APTUS Hand System

Also marketed or referenced as:
APTUS Elbow Dorsal Olecranon

K243610 is the FDA 510(k) clearance for APTUS Hand System by Medartis AG. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K243610 · Medartis AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
105d
Days
Class 2
Risk

K243610 is an FDA 510(k) clearance for the APTUS Hand 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 March 7, 2025 after a review of 105 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 K243610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2024
Decision Date March 07, 2025
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
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 K243610.
TriMed Ankle Fixation System
K243999 · TriMed, Inc. · Mar 2025
The OsteoCentric Bone Plate and Screw System
K250494 · OsteoCentric Technologies · Mar 2025
BPS Wrist Fracture System
K250498 · Orthonovis, Inc. · Mar 2025
CastleLoc Pectus Bar System
K243357 · L & K Biomed Co., Ltd. · Feb 2025
EVOS Pelvic and Acetabular System
K241666 · Smith & Nephew · Feb 2025
A.L.P.S. Small Fragment Plating System
K243761 · Biomet Orthopedics · Feb 2025