Cleared Traditional

K240613 - APTUS Elbow Dorsal Olecranon Plates

K240613 is an FDA 510(k) clearance for APTUS Elbow Dorsal Olecranon Plates, 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 107-day FDA review.

K240613 · Medartis AG · Orthopedic device
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Jun 2024
Decision
107d
Days
Class 2
Risk

K240613 is an FDA 510(k) clearance for the APTUS Elbow Dorsal Olecranon Plates. 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 June 20, 2024 after a review of 107 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 - K240613

510(k) Number K240613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2024
Decision Date June 20, 2024
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
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 Peers - HRS Plate, Fixation, Bone

All 1005
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K240613.
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