# K261511: Xpert Ankle

- Pathway: 510(k) (Traditional)
- Applicant: Newclip Technics
- Decided: Jul 28, 2026 after 82 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: 16 generations back to K962616 (1996). 179 ancestors in all.
No later device cites it as a predicate yet.
0 of 180 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173641: Activ Ankle, Newclip Technics (2018) Summary page 6.
- K151732: Arthrex Fracture Plates, Arthrex, Inc. (2015) Summary page 6.
- K080522: Synthes 3.5 MM LCP Distal Tibia T Plates, Synthes (Usa) (2008) Summary page 6.

## Indications for use
The implants of the Xpert Ankle range are intended for the fixation of fractures, osteotomies and pseudarthroses of the distal and the diaphyseal fibula, the distal tibia and for the syndesmotic repair in adults.

Source page: https://510kreport.com/device/K261511
Methodology: https://510kreport.com/methodology