# K203228: DART-FIRE EDGE Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Wright Medical
- Decided: May 11, 2021 after 190 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: 1 generation back to K082320 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The DART-FIRE EDGE Cannulated Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of foot and ankle bones appropriate for the size of the device. Screws are intended for single use only.

Source page: https://510kreport.com/device/K203228
Methodology: https://510kreport.com/methodology