# K163226: EPIC Extremely Small Staple

- Pathway: 510(k) (Traditional)
- Applicant: Epic Extremely, LLC
- Decided: May 16, 2017 after 180 days
- Product code: JDR (Staple, 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: 5 generations back to K902307 (1990). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043059: Compression Staple and Simple Staple, Wrightmedicaltechnologyinc (2005) Summary page 4.
- K162354: Sniper Staple System, Trilliant Surgical, Ltd. (2017). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K180544: DePuy Synthes Static Staples (2018), 0 descendants of its own

## Indications for use
The EPIC Extremity Small Staple is indicated for use in fixation of bone fractures or bone reconstruction. Examples include: *Wedge osteotomy of the first phalanx (Akin osteotomy) *Treatment of hallux valgus in order to correct valgus or pronation of the first ray *Wind swept toes The Small Staple is intended for single use only

Source page: https://510kreport.com/device/K163226
Methodology: https://510kreport.com/methodology