# K153340: Epic Extremity Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Epic Extremity, LLC
- Decided: Feb 9, 2016 after 82 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K022325 (2002). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061808: Darco Locking Bone Plate System, Darco International, Inc. (2006) Summary page 4.

## Most influential descendants
- K172441: EPIC Extremity Fracture Plate System (2017), 1 descendant of its own
- K223933: Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws (2023), 0 descendants of its own
- K182991: EPIC Extremity Fusion Plate System (2019), 0 descendants of its own

## Recalls of this device
- Mar 20, 2018 · Class II · Z-1874-2018: There is an error in the caddy artwork that misidentifies a specific plate and screw.
- Mar 20, 2018 · Class II · Z-1875-2018: There is an error in the caddy artwork that misidentifies a specific plate and screw.

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

Source page: https://510kreport.com/device/K153340
Methodology: https://510kreport.com/methodology