# K172441: EPIC Extremity Fracture Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Epic Extremity, LLC
- Decided: Nov 6, 2017 after 87 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: 3 generations back to K022325 (2002). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153340: Epic Extremity Plate System, Epic Extremity, LLC (2016) Summary page 4.

## Most influential descendants
- K182991: EPIC Extremity Fusion Plate System (2019), 0 descendants of its own

## Indications for use
The EPIC Extremity Fracture Plate System is indicated for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. The plates/screws are intended for single use only.

Source page: https://510kreport.com/device/K172441
Methodology: https://510kreport.com/methodology