# K120689: Synthes 3.5 MM VA-LCP Proximal Tibia Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Jun 4, 2012 after 90 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: 8 generations back to K962616 (1996). 38 ancestors in all.
28 later devices descend from it; 8 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011978: Synthes LCP Proximal Tibia Plate, Synthes (Usa) (2001)
- K052390: Synthes LCP Proximal Tibia Plates Line Extension, Synthes (Usa) (2005) Summary page 1.
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.
- K083286: Orthopediatrics Pediloc Locking Plate System, OrthoPediatrics Corp. (2009) Summary page 1.

## Most influential descendants
- K213864: Bonebridge Osteosynthesis Plating System (2022), 8 descendants of its own
- K231292: TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System (2023), 7 descendants of its own
- K141527: Depuy Synthes Variable Angle Locking Hand System (2015), 7 descendants of its own
- K162124: Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins (2017), 6 descendants of its own
- K240318: SITTER 3.5mm Versatile System (2024), 4 descendants of its own

## Indications for use
The Synthes 3.5 mm VA-LCP Proximal Tibia Plates are intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of* lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, malunions, tibial osteotomies and osteopenic bone.

Source page: https://510kreport.com/device/K120689
Methodology: https://510kreport.com/methodology