# K091479: Aptus Foot System

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Jul 13, 2009 after 55 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
51 later devices descend from it; 9 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K110908: Aptus Foot 3.5 System (2011), 25 descendants of its own
- K142581: APTUS Foot System (2015), 22 descendants of its own
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own
- K193633: APTUS® Ankle Trauma System 2.8/3.5 (2020), 11 descendants of its own
- K193222: Tyber Medical Anatomical Plating System (2020), 11 descendants of its own

## Recalls of this device
- Jan 9, 2026 · Class II · Z-1550-2026: Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
- Apr 12, 2024 · Class II · Z-1821-2024: Screw is 16mm long instead of 22mm long.

## 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/K091479
Methodology: https://510kreport.com/methodology