# K142581: APTUS Foot System

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Apr 9, 2015 after 206 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: 10 generations back to K962616 (1996). 94 ancestors in all.
22 later devices descend from it; 3 cite it directly.
0 of 117 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 5.
- K071264: Synthes (Usa) 2.4/2.7 MM Locking Foot Module, Synthes (Usa) (2007) Summary page 5.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 5.
- K090949: Synthes (Usa) 1.5MM Headless Compression Screws, Synthes (Usa) (2009) Summary page 5.
- K101700: IO Fix Hand, IO Fix Foot, Extremity Medical Screw System, Extremity Medical, LLC (2010) Summary page 5.

## Most influential descendants
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own
- K193222: Tyber Medical Anatomical Plating System (2020), 11 descendants of its own
- K203817: Tyber Medical Anatomical Plating System (2021), 10 descendants of its own
- K222465: Tyber Medical Anatomical Plating System (2023), 9 descendants of its own
- K183011: Additive Orthopaedics Patient Specific 3D Locking Lattice Plates (2019), 5 descendants of its own

## 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/K142581
Methodology: https://510kreport.com/methodology