# K191636: APTUS Foot System

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Aug 16, 2019 after 58 days
- Product code: JDR (Staple, 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: 11 generations back to K962616 (1996). 96 ancestors in all.
No later device cites it as a predicate yet.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991566: Solustaple, New Deal, S.A. (1999) Summary page 4.
- K142581: APTUS Foot System, Medartis AG (2015) Summary page 4.

## Indications for use
The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.

Source page: https://510kreport.com/device/K191636
Methodology: https://510kreport.com/methodology