# K254253: LOQTEQ® VA Proximal Humerus Plate 3.5

- Pathway: 510(k) (Traditional)
- Applicant: Aap Implantate AG
- Decided: Mar 24, 2026 after 85 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: 3 generations back to K011815 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211582: LOQTEQ Proximal Humerus Plate 3.5 System, Aap Implantate AG (2021) Summary page 5.

## Indications for use
LOQTEQ® VA Proximal Humerus Plate 3.5 is indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K254253
Methodology: https://510kreport.com/methodology