APTUS Shoulder Proximal Humerus System, PentaLock 3.5— 510(k) K253916

Name: FDA 510(k) clearance K253916
Creator: U.S. Food and Drug Administration
Published: 2026-03-16

Substantially Equivalent

Medartis AG

FDA 510(k) clearance K253916 for APTUS Shoulder Proximal Humerus System, PentaLock 3.5, Substantially Equivalent on 2026-03-16. Applicant: Medartis AG. Device class: 2.

Clearance details

Applicant: Medartis AG
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-12-08
Decision date: 2026-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basel, CH

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.