# K131782: Loqteq High Tibia Osteotomy Plate 4.5

- Pathway: 510(k) (Traditional)
- Applicant: Aap Implantate AG
- Decided: Nov 18, 2013 after 154 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 K023941 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023941: Synthes Tomofix Osteotomy System, Synthes (Usa) (2003) Summary page 1.
- K081353: Synthes (Usa) Tomofix Medial Distal Femur Plates, Synthes (Usa) (2008) Summary page 1.

## Indications for use
The indication for use of the aap LOQTEQ® Osteotomy System are: LOQTEQ® High Tibial Osteotomy Plate 4.5: * Open-wedge osteotomies at the proximal medial tibia * Treatment of bone and joint deformities * Treatment of malpositions caused by injuries or disorders such as osteoarthritis LOQTEQ® Distal Femur Osteotomy Plate 4.5: * Closed-wedge osteotomies of the medial distal femur * Treatment of bone and joint deformities * Treatment of malpositions caused by injuries or disorders such as osteoarthritis

Source page: https://510kreport.com/device/K131782
Methodology: https://510kreport.com/methodology