# K181425: APTUS® Proximal Humerus System

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Aug 5, 2018 after 66 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: 5 generations back to K042059 (2004). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 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) Summary page 4.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 4.
- K092038: Aptus K-Wire System, Medartis AG (2009) Summary page 4.
- K960385: Sterile Kirschner Wires and Steinmann Pins, Depuy, Inc. (1996) Summary page 4.

## Most influential descendants
- K253916: APTUS Shoulder Proximal Humerus System, PentaLock 3.5 (2026), 0 descendants of its own

## Indications for use
APTUS® Proximal Humerus System is indicated for fractures, osteotomies and non-unions of the proximal humerus. The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

Source page: https://510kreport.com/device/K181425
Methodology: https://510kreport.com/methodology