# K113601: Aap  Loqteq Distal Medial Tibia Plate 3.5 System

- Pathway: 510(k) (Traditional)
- Applicant: Aap Implantate AG
- Decided: Nov 8, 2012 after 339 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 K013248 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 1.

## Indications for use
The aap LOQTEQr Distal Medial Tibia Plate 3.5 System is intended for * Fixation of complex intra- and extra-articular fractures of the distal tibia * Osteotomies of the distal tibia

Source page: https://510kreport.com/device/K113601
Methodology: https://510kreport.com/methodology