# K140675: Emerge External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Emerge Medical, Inc.
- Decided: Jun 10, 2014 after 84 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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: 1 generation back to K082650 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082650: Synthes Large External Fixation, MR Conditional, Synthes (Usa) (2008) Summary page 2.

## Most influential descendants
- K150579: Cardinal Health External Fixation System (2015), 0 descendants of its own

## Indications for use
The Emerge External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. The system can be used for: Stabilization of soft tissues and fractures Polytrauma/multiple orthopedic trauma Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures Arthrodeses and osteotomies with soft tissue problems; failures of total joints Neutralization of fractures stabilized with limited internal fixation Non-unions/septic non-unions Intra-operative reductions/stabilization tool to assist with indirect reduction Unilateral rectilinear bone segment transport or leg lengthening

Source page: https://510kreport.com/device/K140675
Methodology: https://510kreport.com/methodology