# K192297: APTUS Wrist Arthrodesis Plates

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Nov 8, 2019 after 77 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 K962616 (1996). 22 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112169: Aptus Wrist Arthrodesis Plates, Medartis AG (2012) Summary page 4.

## Most influential descendants
- K223853: Medartis APTUS® Ulna Plates (2023), 5 descendants of its own
- K234062: APTUS Hand Scaphoid Plates (2024), 3 descendants of its own
- K232144: Sterile Products of the APTUS System (2023), 3 descendants of its own
- K243610: APTUS Hand System; APTUS Elbow Dorsal Olecranon (2025), 2 descendants of its own
- K260761: APTUS Clavicle System 2.8 (2026), 0 descendants of its own

## Indications for use
APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.

Source page: https://510kreport.com/device/K192297
Methodology: https://510kreport.com/methodology