# K110354: 4.5MM VA-LCP Curved Condylar Plate System

- Pathway: 510(k) (Special)
- Applicant: Synthes USA
- Decided: Mar 4, 2011 after 25 days
- Product code: JDP (Condylar Plate Fixation Implant)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K982222 (1998). 6 ancestors in all.
62 later devices descend from it; 6 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083025: Synthes 4.5 MM VA-LCP Curved Condylar System, Synthes (Usa) (2009) Summary page 1.
- K000066: Synthes (Usa) Locking Condylar Plate (LCP) System, Synthes (Usa) (2000) Summary page 1.
- K041911: Synthes (Usa) LCP Curved Plates, Synthes (Usa) (2004)
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 1.
- K041533: Synthes (Usa) [Synthes} Peri-Prosthetic Screws, Synthes (Usa) (2004) Summary page 1.

## Most influential descendants
- 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
- K143061: Activ Ankle Locking Plating System (2015), 8 descendants of its own

## Recalls of this device
- Feb 5, 2014 · Class II · Z-1125-2014: Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved
- May 29, 2013 · Class II · Z-0401-2014: A plate was inadvertently released to a sales consultant that was restricted for sale.

## Indications for use
The Synthes 4.5mm VA-LCP Curved Condylar Plate System is indicated for buttressing mutifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nontunions and malunions.

Source page: https://510kreport.com/device/K110354
Methodology: https://510kreport.com/methodology