# K193633: APTUS® Ankle Trauma System 2.8/3.5

- 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: 3 generations back to K882831 (1988). 13 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 4.
- K092812: Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates, Synthes (Usa) (2010) Summary page 4.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 4.
- K083213: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 4.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.
- K091479: Aptus Foot System, Medartis AG (2009) Summary page 4.

## Most influential descendants
- K223853: Medartis APTUS® Ulna Plates (2023), 5 descendants of its own
- K240613: APTUS Elbow Dorsal Olecranon Plates (2024), 4 descendants of its own
- K234062: APTUS Hand Scaphoid Plates (2024), 3 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

## Indications for use
APTUS® Ankle Trauma System 2.8/3.5 is indicated for fractures, osteotomies, malunions and non-unions of the distal tibia and fibula.

Source page: https://510kreport.com/device/K193633
Methodology: https://510kreport.com/methodology