# K260761: APTUS Clavicle System 2.8

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Jun 5, 2026 after 88 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: 13 generations back to K792022 (1979). 173 ancestors in all.
No later device cites it as a predicate yet.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192984: APTUS Clavicle System, Medartis AG (2020) Summary page 5.
- K111540: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2011) Summary page 5.
- K243610: APTUS Hand System; APTUS Elbow Dorsal Olecranon, Medartis AG (2025) Summary page 5.
- K061753: Synthes (Usa) Clavicle Hook Plates, Synthes (Usa) (2006) Summary page 5.

## Indications for use
Implants from the APTUS Clavicle System are indicated for the treatment of fractures and osteotomies of the clavicle, and for dislocations of the acromioclavicular joint. Clavicle plates - fractures, osteotomies, malunions and non-unions of the clavicle Clavicle Hook Plates - fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

Source page: https://510kreport.com/device/K260761
Methodology: https://510kreport.com/methodology