# K191848: APTUS Wrist Spanning Plates 2.5

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Sep 30, 2019 after 82 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: 7 generations back to K962616 (1996). 34 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142906: APTUS Wrist 2.5 System, Medartis AG (2015) Summary page 4.
- K131764: Acumed Wrist Spanning Plate, Acumed, LLC (2013) Summary page 4.

## Most influential descendants
- K243308: Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) (2024), 1 descendant of its own
- K261351: SALGINA 2.5mm Distal Radius System (2026), 0 descendants of its own

## Indications for use
APTUS® Wrist Spanning Plates 2.5 are intended for use in forearm fractures.

Source page: https://510kreport.com/device/K191848
Methodology: https://510kreport.com/methodology