# K120854: Synthes VA LCP Ankle Trauma System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA
- Decided: Jun 18, 2012 after 89 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). 96 ancestors in all.
44 later devices descend from it; 9 cite it directly.
0 of 141 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033805: Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal Plates, Synthes (Usa) (2004) Summary page 1.
- K083213: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 1.
- K073460: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 1.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001)
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011)
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 1.
- K110354: 4.5MM VA-LCP Curved Condylar Plate System, Synthes USA (2011) Summary page 1.
- K120070: Synthes Variable Angle LCP Elbow System, Synthes USA (2012) Summary page 1.
- K120717: Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates), Synthes USA (2012). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K143385: Acumed Ankle Plating System (2015), 23 descendants of its own
- K151886: Acumed Ankle and Small Fragment Base Set Update (2015), 15 descendants of its own
- K181113: CoLink™ Afx Plating System (2018), 14 descendants of its own
- K143061: Activ Ankle Locking Plating System (2015), 8 descendants of its own
- K191535: CoLink® Mini Plating System (2019), 6 descendants of its own

## Indications for use
The Synthes Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically, * Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, * Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and * Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

Source page: https://510kreport.com/device/K120854
Methodology: https://510kreport.com/methodology