# K161861: APTUS® Coronoid 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Feb 9, 2017 after 218 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: 7 generations back to K962616 (1996). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071715: Acumed Congruent Bone Plate System, Acumed, LLC (2007) Summary page 5.
- K142906: APTUS Wrist 2.5 System, Medartis AG (2015) Summary page 5.

## Indications for use
APTUS Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.

Source page: https://510kreport.com/device/K161861
Methodology: https://510kreport.com/methodology