# K233994: VOLT™ Proximal Humerus 3.5 Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes GmbH
- Decided: Jul 26, 2024 after 221 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: 1 generation back to K011815 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 4.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 4.

## Indications for use
The DePuy Synthes VOLTTM Proximal Humerus 3.5 Plating System is indicated for internal fixation of proximal humerus fractures in adults and adolescents (12-21 years) where growth plates have fused. VOLT™ Proximal Humerus Plates: Indicated for fractures of the proximal end segment of the humerus. VOLT™ Proximal Humerus Plates, Long: Indicated for fractures of the proximal end segment and/or diaphyseal segment of the humerus.

Source page: https://510kreport.com/device/K233994
Methodology: https://510kreport.com/methodology