# K260228: POYA 3.5mm Medial Proximal Tibia System

- Pathway: 510(k) (Traditional)
- Applicant: Bonebridge AG
- Decided: Apr 24, 2026 after 88 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: 15 generations back to K962616 (1996). 135 ancestors in all.
No later device cites it as a predicate yet.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242399: Bonebridge Osteosynthesis Plating System, Bonebridge AG (2024) Summary page 6.
- K231292: TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System, Bonebridge AG (2023) Summary page 6.
- K032269: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 6.

## Indications for use
The POYA 3.5mm Medial Proximal Tibia System is intended for adult patients and indicated to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or de-pression fractures of the medial tibia plateau. Also, for use in the fixation of osteo-penic bone and fixation of nonunions and malunions of the medial proximal tibia. Additionally, the lonqer plates are indicated for fractures extendinq to the tibial shaft.

Source page: https://510kreport.com/device/K260228
Methodology: https://510kreport.com/methodology