# K120070: Synthes Variable Angle LCP Elbow System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA
- Decided: Mar 21, 2012 after 72 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962616 (1996). 79 ancestors in all.
76 later devices descend from it; 15 cite it directly.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 1.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 1.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 1.

## Most influential descendants
- K120717: Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates) (2012), 53 descendants of its own
- K120854: Synthes VA LCP Ankle Trauma System (2012), 44 descendants of its own
- 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

## Recalls of this device
- Sep 28, 2015 · Class II · Z-0124-2016: The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.410S was incorrectly etched with part number 02.117.610S

## Indications for use
The Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, * Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. * Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.

Source page: https://510kreport.com/device/K120070
Methodology: https://510kreport.com/methodology