# K132554: Aap Loqteq Proximal Medial Tibia Plate 3.5

- Pathway: 510(k) (Traditional)
- Applicant: Aap Implantate AG
- Decided: Oct 3, 2013 after 50 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 K023802 (2003). 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)
- K050646: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates, Synthes (Usa) (2005) Summary page 1.
- K023802: Synthes 4.5 MM Titanium LCP Proximal Tibia Plating System, Synthes (Usa) (2003) Summary page 1.

## Most influential descendants
- K220199: AFFINITY Proximal Tibia System (2022), 0 descendants of its own

## Indications for use
The aap LOQTEQ Proximal Medial Tibia Plate 3.5 is indicated for * Metaphyseal fractures of the medial tibial plateau * Split fractures of the medial tibial plateau * Medial split fractures with depression * Split or depression fracture of the medial tibial plateau In addition, the plates may be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as multi-fragment fractures of the proximal tibia. The aap LOQTEQ Proximal Lateral Tibia Plate 3.5 is indicated for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, and fractures with associated shaft fractures.

Source page: https://510kreport.com/device/K132554
Methodology: https://510kreport.com/methodology