# K110908: Aptus Foot 3.5 System

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Jun 28, 2011 after 89 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: 2 generations back to K981372 (1998). 3 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991407: Synthes Locking Calcaneal Plates, Synthes (Usa) (1999) Summary page 2.
- K091479: Aptus Foot System, Medartis AG (2009) Summary page 2.

## 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 3.5 System is indicated for fractures and osteotomies of the calcaneus.

Source page: https://510kreport.com/device/K110908
Methodology: https://510kreport.com/methodology