# K193639: APTUS® Foot 2.8-3.5 System

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Mar 26, 2020 after 90 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: 6 generations back to K000684 (2000). 16 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 26 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 4.
- K061808: Darco Locking Bone Plate System, Darco International, Inc. (2006) Summary page 4.
- K052614: Low Profile Plate and Screw System, Arthrex, Inc. (2005) Summary page 4.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.

## Most influential descendants
- K240613: APTUS Elbow Dorsal Olecranon Plates (2024), 4 descendants of its own
- K243610: APTUS Hand System; APTUS Elbow Dorsal Olecranon (2025), 2 descendants of its own
- K230971: APTUS® 3.5 TriLock Straight Plates (2023), 2 descendants of its own
- K232251: APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension (2023), 1 descendant of its own
- K260761: APTUS Clavicle System 2.8 (2026), 0 descendants of its own

## Indications for use
The APTUS® Foot 2.8-3.5 System is intended for use in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.

Source page: https://510kreport.com/device/K193639
Methodology: https://510kreport.com/methodology