# K223853: Medartis APTUS® Ulna Plates

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Mar 30, 2023 after 97 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: 10 generations back to K792022 (1979). 98 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K193554: APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System, Medartis AG (2020) Summary page 4.
- K192984: APTUS Clavicle System, Medartis AG (2020) Summary page 4.
- K192297: APTUS Wrist Arthrodesis Plates, Medartis AG (2019) Summary page 4.
- K142906: APTUS Wrist 2.5 System, Medartis AG (2015) Summary page 4.

## Most influential descendants
- 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
- K260761: APTUS Clavicle System 2.8 (2026), 0 descendants of its own
- K253916: APTUS Shoulder Proximal Humerus System, PentaLock 3.5 (2026), 0 descendants of its own
- K232105: APTUS Foot System 2.8-3.5 (2024), 0 descendants of its own

## Indications for use
APTUS Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna

Source page: https://510kreport.com/device/K223853
Methodology: https://510kreport.com/methodology