# K161747: LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5

- Pathway: 510(k) (Traditional)
- Applicant: Aap Implantate AG
- Decided: Nov 22, 2016 after 151 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: 4 generations back to K000684 (2000). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113652: Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15, Self Tapping Loqteq Cortical Screw 3.5, T15, Self T, Aap Implantate AG (2012) Summary page 4.
- K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 4.
- K092812: Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates, Synthes (Usa) (2010) Summary page 4.

## Indications for use
LOQTEQ® VA Distal Medial Tibia Plate 3.5 * Fixation of complex intra- and extra-articular fractures of the distal tibia; osteotomies of the distal tibia LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5 * fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone LOQTEQ® VA Distal Fibula Plate 2.7/3.5 * fractures, osteotomies, and non-unions of the distal fibula, especially in osteopenic bone

Source page: https://510kreport.com/device/K161747
Methodology: https://510kreport.com/methodology