# K254093: DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes GmbH
- Decided: Mar 10, 2026 after 81 days
- 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). 111 ancestors in all.
No later device cites it as a predicate yet.
0 of 112 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.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 5.

## Indications for use
The VOLT™ Medial Distal Femur 3.5 Plating System is indicated for internal fixation of isolated medial condylar fractures as a standalone fixation device. For all other distal femur fractures, corrective osteotomies, non-unions, or malunions, it is indicated for use as an adjunct to primary fixation. The VOLT™ Medial Distal Femur 3.5 Plating System is intended for adults and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.

Source page: https://510kreport.com/device/K254093
Methodology: https://510kreport.com/methodology