# K112560: Aptus (R) Distal Humerus System

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Dec 15, 2011 after 104 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: 8 generations back to K962616 (1996). 27 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091479: Aptus Foot System, Medartis AG (2009) Summary page 2.
- K103332: Aptus Ulna Plates, Medartis AG (2011) Summary page 2.
- K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 2.
- K101056: Variax Elbow System, Howmedica Osteonics Corp. (2010) Summary page 2.

## Most influential descendants
- K171285: ARIX Diaphysis System (2017), 6 descendants of its own
- K172008: ARIX Humerus System (2017), 3 descendants of its own
- K202912: ARIX Ankle Distal Tibia System (2020), 1 descendant of its own
- K180972: ARIX Clavicle System (2018), 1 descendant of its own
- K232115: TDM Large Bone Plate and Screw System (2024), 0 descendants of its own

## Indications for use
APTUSO Distal FHumeruLs System is indicated for fractures, osteotomies and non-unions of the distal humeuLs.

Source page: https://510kreport.com/device/K112560
Methodology: https://510kreport.com/methodology