# K121495: Loqteq Proximal Humerus Plate 3.5, Short Loqteq Proximal Humerus Plate 3.5, Long

- Pathway: 510(k) (Traditional)
- Applicant: Aap Implantate AG
- Decided: Dec 7, 2012 after 200 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: 1 generation back to K011815 (2001). 2 ancestors in all.
2 later devices descend 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)
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 1.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 1.

## Most influential descendants
- K211582: LOQTEQ Proximal Humerus Plate 3.5 System (2021), 1 descendant of its own
- K254253: LOQTEQ® VA Proximal Humerus Plate 3.5 (2026), 0 descendants of its own

## Indications for use
The aap LOOTEQ6 Proximal Humerus Plate 3.5 System includes LOQTEQO Proximal Humerus Plate 3.5 short and LOQTEQO Proximal Humerus Plate 3.5 long. The plates accept 3.5 mm cortical locking screws and 3.5 mm cortical screws as well as 3.8 mm cancellous locking screws. They are intended for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone

Source page: https://510kreport.com/device/K121495
Methodology: https://510kreport.com/methodology