# K162354: Sniper Staple System

- Pathway: 510(k) (Traditional)
- Applicant: Trilliant Surgical, Ltd.
- Decided: Apr 20, 2017 after 240 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: 4 generations back to K902307 (1990). 6 ancestors in all.
5 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123926: Metasurg Nitinol Staple Implant, Metasurg (2013) Summary page 4.
- K123363: Super Staple (TM) Classic, Metric Medical Devices, Inc. (2013) Summary page 4.
- (no number) Smith and Nephew Richards Staple: named in the summary without a submission number

## Most influential descendants
- K172405: Sniper Staple System, Non-Sterile (2017), 1 descendant of its own
- K163226: EPIC Extremely Small Staple (2017), 1 descendant of its own
- K232905: Medline UNITE® REFLEX® Nitinol Staple Kit (2023), 0 descendants of its own
- K181815: DynaBridge (2018), 0 descendants of its own
- K180544: DePuy Synthes Static Staples (2018), 0 descendants of its own

## Indications for use
The Trilliant Surgical Sniper Staple System is indicated for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device.

Source page: https://510kreport.com/device/K162354
Methodology: https://510kreport.com/methodology