# K250155: Xpert Knee

- Pathway: 510(k) (Traditional)
- Applicant: Newclip Technics
- Decided: Apr 23, 2025 after 92 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: 9 generations back to K962616 (1996). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120689: Synthes 3.5 MM VA-LCP Proximal Tibia Plate System, Synthes (USA) Products, LLC (2012) Summary page 6.
- K050646: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates, Synthes (Usa) (2005) Summary page 6.
- K082624: Synthes (Usa) 3.5MM LCP Posteromedial Proximal Tibia Plates, Synthes (Usa) (2008) Summary page 6.
- K011978: Synthes LCP Proximal Tibia Plate, Synthes (Usa) (2001) Summary page 6.
- K030597: Synthes 3.5MM Titanium LCP Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 6.

## Indications for use
The implants of Xpert Knee range are indicated for the fixation of fractures, non-unions and malunions of the proximal tibia in adults.

Source page: https://510kreport.com/device/K250155
Methodology: https://510kreport.com/methodology