# K233665: DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Synthes
- Decided: Mar 21, 2024 after 127 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: 12 generations back to K962616 (1996). 110 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 4.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 4.
- K033805: Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal Plates, Synthes (Usa) (2004) Summary page 4.
- K131186: Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot System, Synthes (USA) Products, LLC (2013) Summary page 4.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 4.
- K082072: Synthes (Usa) 3.5MM LCP Hook Plate, Synthes (Usa) (2008) Summary page 4.
- K092247: Synthes Locking Hand Plates, Synthes (Usa) (2009) Summary page 4.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 4.
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 4.
- K150099: Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws), Synthes (USA) Products, LLC (2015) Summary page 4.
- (no number) Synthes 4.0mm Cancellous Screws: named in the summary without a submission number

## Most influential descendants
- K254093: DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System (2026), 0 descendants of its own
- K260069: DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (2026), 0 descendants of its own
- K252191: BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System (2025), 0 descendants of its own
- K251361: Tyber Medical Distal Radius Plating System (2025), 0 descendants of its own

## Indications for use
DePuy Synthes VOLT™ Mini Fragment Plating System: The VOLT™ Mini Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size. The VOLT™ Mini Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation. If used in the femur, tibia, humerus, patella, or pelvis the VOLT™ Mini Fragment Plating System can only be used for non-load bearing stabilization and reduction. DePuy Synthes VOLT™ Small Fragment Plating System: The VOLT Small Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size. The VOLT Small Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation. If used in the femur the VOLT Small Fragment Plating System can only be used for non-load bearing stabilization and reduction.

Source page: https://510kreport.com/device/K233665
Methodology: https://510kreport.com/methodology