# K230141: LOQTEQ® VA Elbow Plates 2.7/3.5 System

- Pathway: 510(k) (Traditional)
- Applicant: Aap Implantate AG
- Decided: Mar 17, 2023 after 58 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: 12 generations back to K962616 (1996). 87 ancestors in all.
No later device cites it as a predicate yet.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132787: Loqteq Distal Dorsolateral Humerus Plate, Aap Implantate AG (2013) Summary page 5.
- K140607: Aap Loqtec (R) Olecranon Plate, Aap Implantate AG (2014) Summary page 5.
- K161696: aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5, Aap Implantate AG (2016) Summary page 5.
- K120717: Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates), Synthes USA (2012) Summary page 5.

## Indications for use
The LOQTEQ® VA Elbow Plates 2.7/3.5 includes the LOQTEQ® VA Distal Medial Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Dorsolateral Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Lateral Humerus Plate 2.7/3.5 and LOQTEQ® VA Olecranon Plate 2.7/3.5. LOQTEQ® VA Distal Medial Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Dorsolateral Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Lateral Humerus Plate 2.7/3.5 are indicated for: • Intra‐articular fractures of the distal humerus • Supracondylar fractures of the distal humerus • Osteotomies, and non‐unions of the distal humerus LOQTEQ® VA Olecranon Plate 2.7/3.5 is indicated for: • Fixation of fractures, osteotomies and non‐unions of the olecranon, particularly in osteopenic bone

Source page: https://510kreport.com/device/K230141
Methodology: https://510kreport.com/methodology