# K210043: LOQTEQ Distal Lateral Femur Plate 4.5 System

- Pathway: 510(k) (Traditional)
- Applicant: Aap Implantate AG
- Decided: Mar 3, 2021 after 55 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 K062564 (2006). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121494: Loqteq Distal Lateral Femur Plate 4.5 (Left and Right Version) Loqreq Cortical Screw 4.5 T25, Self-Tapping, Aap Implantate AG (2012) Summary page 4.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 4.

## Most influential descendants
- K232115: TDM Large Bone Plate and Screw System (2024), 0 descendants of its own

## Indications for use
Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures; fractures in normal or osteopenic bone; non-unions and malunions; and osteotomies of the femur

Source page: https://510kreport.com/device/K210043
Methodology: https://510kreport.com/methodology