# K240613: APTUS Elbow Dorsal Olecranon Plates

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Jun 20, 2024 after 107 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 K962616 (1996). 97 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120070: Synthes Variable Angle LCP Elbow System, Synthes USA (2012) Summary page 4.
- K193633: APTUS® Ankle Trauma System 2.8/3.5, Medartis AG (2020) Summary page 4.
- K193639: APTUS® Foot 2.8-3.5 System, Medartis AG (2020) 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
- K261145: Avanti Distal Elbow ORIF System (2026), 0 descendants of its own
- K253916: APTUS Shoulder Proximal Humerus System, PentaLock 3.5 (2026), 0 descendants of its own

## Indications for use
The APTUS Elbow Dorsal Olecranon Plates are indicated for fractures and osteotomies, in particular for the ulna.

Source page: https://510kreport.com/device/K240613
Methodology: https://510kreport.com/methodology