APTUS Shoulder Proximal Humerus System, PentaLock 3.5— 510(k) K253916
Substantially EquivalentMedartis 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.
Summary
Medartis' APTUS Shoulder Proximal Humerus System, PentaLock 3.5 is filed under HRS, bone fixation plates. The record doesn't list plate sizes or components.
Class II, 21 CFR 888.3030. It was a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.
Medartis filed from Basel, Switzerland. The decision came 98 calendar days after FDA received it (December 8, 2025 to March 16, 2026).
Clearance details
- Applicant
- Medartis AG
- Product code
- Product code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Basel, CH
Recent devices under product code HRS
view allMore clearances from Medartis AG
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . 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.