# K260069: DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes GmbH
- Decided: Mar 9, 2026 after 59 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: 13 generations back to K962616 (1996). 113 ancestors in all.
No later device cites it as a predicate yet.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233665: DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System, DePuy Synthes (2024) Summary page 5.
- K011978: Synthes LCP Proximal Tibia Plate, Synthes (Usa) (2001) Summary page 5.
- K050646: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates, Synthes (Usa) (2005) Summary page 5.
- K082624: Synthes (Usa) 3.5MM LCP Posteromedial Proximal Tibia Plates, Synthes (Usa) (2008) Summary page 5.

## Indications for use
The DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System is indicated for internal fixation of proximal tibia fractures in adults and adolescents (12-21 years) where growth plates have fused. VOLT Proximal Tibia Plates: Indicated for fractures of the proximal end segment of the tibia. VOLT Proximal Tibia Plates, Long: Indicated for fractures of the proximal end segment of the tibia with or without extension into the diaphysis.

Source page: https://510kreport.com/device/K260069
Methodology: https://510kreport.com/methodology