# K232105: APTUS Foot System 2.8-3.5

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Apr 19, 2024 after 280 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: 11 generations back to K792022 (1979). 110 ancestors in all.
No later device cites it as a predicate yet.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193639: APTUS® Foot 2.8-3.5 System, Medartis AG (2020) Summary page 4.
- K223853: Medartis APTUS® Ulna Plates, Medartis AG (2023) Summary page 4.
- K091479: Aptus Foot System, Medartis AG (2009) Summary page 4.
- K052614: Low Profile Plate and Screw System, Arthrex, Inc. (2005) Summary page 4.
- K150520: DARCO Locking Bone Plate System, Wrightmedicaltechnologyinc (2015) Summary page 4.
- K103332: Aptus Ulna Plates, Medartis AG (2011) Summary page 4.
- K193633: APTUS® Ankle Trauma System 2.8/3.5, Medartis AG (2020) Summary page 4.
- K110908: Aptus Foot 3.5 System, Medartis AG (2011) Summary page 4.

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

Source page: https://510kreport.com/device/K232105
Methodology: https://510kreport.com/methodology