# K253916: APTUS Shoulder Proximal Humerus System, PentaLock 3.5

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Mar 16, 2026 after 98 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K792022 (1979). 180 ancestors in all.
No later device cites it as a predicate yet.
0 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120108: Aptus Proximal Humerus System, Medartis AG (2012)
- K181425: APTUS® Proximal Humerus System, Medartis AG (2018)
- K243610: APTUS Hand System; APTUS Elbow Dorsal Olecranon, Medartis AG (2025) Summary page 5.

## Indications for use
APTUS Shoulder Proximal Humerus System, Pentalock 3.5, is indicated for fractures, osteotomies and non-unions of the proximal humerus.

Source page: https://510kreport.com/device/K253916
Methodology: https://510kreport.com/methodology