# K243610: APTUS Hand System; APTUS Elbow Dorsal Olecranon

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Mar 7, 2025 after 105 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: 12 generations back to K792022 (1979). 171 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051567: Aptus Titanium Osteosynthesis System, Medartis, Inc. (2005) Summary page 5.
- K240613: APTUS Elbow Dorsal Olecranon Plates, Medartis AG (2024) Summary page 5.
- K232144: Sterile Products of the APTUS System, Medartis AG (2023) Summary page 5.
- K102537: Aptus 1.5 Trilock, Medartis AG (2010) Summary page 5.
- K234062: APTUS Hand Scaphoid Plates, Medartis AG (2024) Summary page 5.

## Most influential descendants
- 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 Fractures, osteotomies and arthrodesis of the bones of the hand - Hand System - fractures of the distal, middle and proximal phalanges - fractures of the metacarpals - osteotomies of the hand - arthrodeses in the hand - Scaphoid plates - fractures and non-unions of the scaphoid The APTUS Elbow Dorsal Olecranon Plates are indicated for fractures and osteotomies, in particular for the ulna.

Source page: https://510kreport.com/device/K243610
Methodology: https://510kreport.com/methodology