# K193554: APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Feb 16, 2020 after 58 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). 21 ancestors in all.
8 later devices descend from it; 3 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)
- K142906: APTUS Wrist 2.5 System, Medartis AG (2015) 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® Forearm Shaft Plates are intended for management of fractures and osteotomies of the radius and ulna shaft. APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.

Source page: https://510kreport.com/device/K193554
Methodology: https://510kreport.com/methodology