# K163038: EPIC Extremity Snap-Off Screw

- Pathway: 510(k) (Traditional)
- Applicant: Epic Extremity, LLC
- Decided: Feb 28, 2017 after 120 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 K043583 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043583: Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003, Wrightmedicaltechnologyinc (2005) Summary page 4.
- K133713: Charlotte (TM) Snap-Off Screw, Wrightmedicaltechnologyinc (2014) Summary page 4.

## Cited in the summary but kept off the family tree
- K153333: Epic Extremity Cannulated Screw System, Epic Extremity, LLC (2016). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The EPIC Extremity Snap-Off Screw is indicated for use in fixation of bone fractures or bone reconstruction. Examples include: *Fixation of small bone fragments *Weil osteotomy *Mono-cortical fixation *Osteotomies and fracture fixation in the foot and hand The Snap-Off Screw is intended for single use only.

Source page: https://510kreport.com/device/K163038
Methodology: https://510kreport.com/methodology