# K153333: Epic Extremity Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Epic Extremity, LLC
- Decided: Jan 19, 2016 after 61 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K810205 (1981). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082320: Darco Small Screw, Wrightmedicaltechnologyinc (2008) Summary page 4.
- K080101: Aap Cannulated Screw and Darco Headed Screw, Aap Implantate AG (2008) Summary page 4.

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

## Indications for use
The Epic Extremity Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

Source page: https://510kreport.com/device/K153333
Methodology: https://510kreport.com/methodology