# K234062: APTUS Hand Scaphoid Plates

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Mar 21, 2024 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: 11 generations back to K792022 (1979). 100 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K102537: Aptus 1.5 Trilock, Medartis AG (2010) Summary page 4.
- K223853: Medartis APTUS® Ulna Plates, Medartis AG (2023) Summary page 4.

## Most influential descendants
- 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

## Indications for use
APTUS Hand Scaphoid Plates are indicated for fractures and non-unions of the scaphoid.

Source page: https://510kreport.com/device/K234062
Methodology: https://510kreport.com/methodology