# K161703: LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer

- Pathway: 510(k) (Traditional)
- Applicant: Aap Implantate AG
- Decided: Nov 4, 2016 after 137 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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.
- K072411: Aap Bone Plates and Screw Implants, Aap Implantate AG (2008) Summary page 4.
- K990776: Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM, Aap Implantate AG (1999) Summary page 4.

## Indications for use
Fractures, osteotomies and non-unions of the distal fibula, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K161703
Methodology: https://510kreport.com/methodology