# K254054: VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes GmbH
- Decided: Mar 2, 2026 after 75 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: 10 generations back to K962616 (1996). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 5.
- K991407: Synthes Locking Calcaneal Plates, Synthes (Usa) (1999) Summary page 5.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 5.
- K211051: DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System), DePuy Synthes (2021) Summary page 5.

## Indications for use
The VOLT™ Ankle Trauma 2.7/3.5 Plating System is indicated for fractures, non-unions and deformity corrections in the distal tibia and distal fibula. The VOLT™ Ankle Trauma 2.7/3.5 Plating System is intended for internal fixation/stabilization of bone fragments of distal tibia & distal fibula for adults and adolescents (12-21 years) where growth plates have fused. The VOLT™ Calcaneus 2.7 Plating System is indicated for fractures, non-unions and deformity corrections in the calcaneus The VOLT™ Calcaneus 2.7 Plating System is intended for internal fixation/stabilization of bone fragments of distal tibia & distal fibula for adults and adolescents (12-21 years) where growth plates have fused.

Source page: https://510kreport.com/device/K254054
Methodology: https://510kreport.com/methodology