# K162124: Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Synthes
- Decided: Mar 29, 2017 after 240 days
- Product code: JDP (Condylar Plate Fixation Implant)
- 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: 9 generations back to K962616 (1996). 43 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110354: 4.5MM VA-LCP Curved Condylar Plate System, Synthes USA (2011) Summary page 5.
- K120689: Synthes 3.5 MM VA-LCP Proximal Tibia Plate System, Synthes (USA) Products, LLC (2012) Summary page 5.

## Most influential descendants
- K172975: DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional (2018), 2 descendants of its own
- K243995: Arthrex Humeral Plating System and Cerclage Button (2025), 1 descendant of its own
- K260353: Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (2026), 0 descendants of its own
- K231333: STRETTO™ Cable System (2023), 0 descendants of its own
- K190750: DePuy Synthes Plates and Screws Portfolio (2019), 0 descendants of its own

## Indications for use
The Synthes 4 5mm VA LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur in normal or osteopenic bone, nonunions and malunions. The DePuy Synthes Vanable Angle Positioning Pins are intended for use with cerclage multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant. The Variable Angle Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0 mm variable angle bone screws.

Source page: https://510kreport.com/device/K162124
Methodology: https://510kreport.com/methodology