# K192984: APTUS Clavicle System

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Jan 24, 2020 after 91 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: 9 generations back to K792022 (1979). 56 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111540: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2011) Summary page 4.
- K073186: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2007) Summary page 4.
- K101536: 2.7/3.5MM VA-LCP Anteriro Clavicle Plate System, Synthes (Usa), LLC (2010) Summary page 4.
- K112111: Acu-Sinch Repair System and Acumed Suture Anchor, Acumed, LLC (2011) Summary page 4.

## Most influential descendants
- K223853: Medartis APTUS® Ulna Plates (2023), 5 descendants of its own
- 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

## Indications for use
APTUS® Clavicle System is indicated for treatment of fractures, osteotomies, malunions and non-unions of the clavicle.

Source page: https://510kreport.com/device/K192984
Methodology: https://510kreport.com/methodology