# K180544: DePuy Synthes Static Staples

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Jul 24, 2018 after 145 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: 6 generations back to K902307 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931155: Staple, Fixation Bone; Screw Fixation Bone, Roseburg SA (1994) Summary page 4.
- K162354: Sniper Staple System, Trilliant Surgical, Ltd. (2017) Summary page 4.
- K163226: EPIC Extremely Small Staple, Epic Extremely, LLC (2017) Summary page 4.

## Indications for use
The DePuy Synthes Static Staples are indicated for extra-articular closing-wedge osteotomies of the 1st ray of the forefoot.

Source page: https://510kreport.com/device/K180544
Methodology: https://510kreport.com/methodology