# K120108: Aptus Proximal Humerus System

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Apr 27, 2012 after 105 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: 4 generations back to K042059 (2004). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001)
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 2.
- K093978: Exactech Equinoxe Proximal Humerus Fracture Plate System, Exactech, Inc. (2010) Summary page 2.

## Most influential descendants
- K181425: APTUS® Proximal Humerus System (2018), 1 descendant of its own
- 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.

Source page: https://510kreport.com/device/K120108
Methodology: https://510kreport.com/methodology