# K182991: EPIC Extremity Fusion Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Epic Extremity, LLC
- Decided: Feb 13, 2019 after 107 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: 13 generations back to K010612 (2001). 114 ancestors in all.
No later device cites it as a predicate yet.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172441: EPIC Extremity Fracture Plate System, Epic Extremity, LLC (2017) Summary page 4.
- K153333: Epic Extremity Cannulated Screw System, Epic Extremity, LLC (2016) Summary page 4.
- K121425: Ortholoc 3DI Ankle Fusion Plating System, Wrightmedicaltechnologyinc (2012) Summary page 4.
- K163650: ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension, Wrightmedicaltechnologyinc (2017) Summary page 4.

## Indications for use
The EPIC Extremity Fusion Plate System is indicated for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet and ankles, including distal tibia. The plates/screws are intended for single use only.

Source page: https://510kreport.com/device/K182991
Methodology: https://510kreport.com/methodology