# K140119: Emerge Medical Periarticular and Locking Large Fragment System

- Pathway: 510(k) (Traditional)
- Applicant: Emerge Medical
- Decided: Mar 12, 2014 after 55 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: 4 generations back to K981372 (1998). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 2.
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 2.
- K041911: Synthes (Usa) LCP Curved Plates, Synthes (Usa) (2004) Summary page 2.
- K000066: Synthes (Usa) Locking Condylar Plate (LCP) System, Synthes (Usa) (2000) Summary page 2.
- K110354: 4.5MM VA-LCP Curved Condylar Plate System, Synthes USA (2011) Summary page 2.
- K083025: Synthes 4.5 MM VA-LCP Curved Condylar System, Synthes (Usa) (2009) Summary page 2.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 2.
- K010766: Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T Plate, Synthes (Usa) (2001) Summary page 2.
- K011978: Synthes LCP Proximal Tibia Plate, Synthes (Usa) (2001)
- K002361: Synthes (Usa) Locking Proximal Plating (L-PTP) System, Synthes (Usa) (2000) Summary page 2.
- K983787: Synthes Proximal Tibia Plating System, Synthes (Usa) (1999) Summary page 2.

## Most influential descendants
- K141347: Emerge Medical IM Nail System (2014), 0 descendants of its own

## Indications for use
The indications for the Emerge Medical Periarticular and Locking Large Fragment System are as follows for the two subsystems: The Emerge Medical Periarticular Lacking Plate Set is intended for treatment of nonunions. mal unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, periprosthetic fractures, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. The Periarticular Locking Plate Set is also intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular Condylar fractures, fractures in normal or osteopenic bone, periprosthetic fractures, and nonunions and malunions. The Emerge Medical Locking Large Fragment Set is intended for fixation of various long bones, such as the humerus, femur, and tibia. Emerge Medical Locking Large Fragment Set is also intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau, and distal tibia. The set is also for use in fixation of periprosthetic fractures, osteopenic bone, and nonunions or malunions.

Source page: https://510kreport.com/device/K140119
Methodology: https://510kreport.com/methodology