# K211582: LOQTEQ Proximal Humerus Plate 3.5 System

- Pathway: 510(k) (Traditional)
- Applicant: Aap Implantate AG
- Decided: Oct 18, 2021 after 150 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: 2 generations back to K011815 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121495: Loqteq Proximal Humerus Plate 3.5, Short Loqteq Proximal Humerus Plate 3.5, Long, Aap Implantate AG (2012) Summary page 4.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 4.

## Most influential descendants
- K254253: LOQTEQ® VA Proximal Humerus Plate 3.5 (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K211582
Methodology: https://510kreport.com/methodology