# K140098: Emerge Medical Small Fragment Locked Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Emerge Medical
- Decided: Mar 12, 2014 after 57 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: 2 generations back to K002361 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983787: Synthes Proximal Tibia Plating System, Synthes (Usa) (1999) Summary page 2.
- K002361: Synthes (Usa) Locking Proximal Plating (L-PTP) System, Synthes (Usa) (2000) Summary page 2.
- K011978: Synthes LCP Proximal Tibia Plate, Synthes (Usa) (2001) Summary page 2.
- K001945: Synthes (Usa) Medial Distal Tibia Plates, Synthes (Usa) (2000) Summary page 2.

## Indications for use
The indications for the Emerge Medical Small Fragment Locked Plating System are as follows for the two subsystems: The Emerge Medical Locking Medial Distal Tibia Plate Set is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures. The Emerge Medical Locking Proximal Tibia Plate Set is intended for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge. bicondylar, combinations of lateral wedge and depression. and fractures with associated shaft fractures.

Source page: https://510kreport.com/device/K140098
Methodology: https://510kreport.com/methodology