# K163440: Stealth Staple System

- Pathway: 510(k) (Traditional)
- Applicant: First Ray, LLC
- Decided: Feb 1, 2017 after 55 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: 7 generations back to K915818 (1992). 50 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153622: First Ray Internal Bone Staple System, First Ray, LLC (2016) Summary page 5.
- K153395: OS2-C Compression Staple, In2bones Sas (2016) Summary page 5.
- K124045: Fuseforce Implant System, Solana Surgical, LLC (2013) Summary page 5.
- (no number) Richards Staple: named in the summary without a submission number

## Most influential descendants
- K220181: StealthFix Intraosseous Fixation System (2022), 1 descendant of its own
- K232324: StealthFix Intraosseous Fixation System (2023), 0 descendants of its own
- K190722: TriMAX Implant System (2019), 0 descendants of its own

## Indications for use
The Stealth Staple System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including: • Arthrodesis in hand or foot surgery • Mono or bi-cortical osteotomies in the foot or hand • Fracture management in the foot or hand • Distal or proximal metatarsal or metacarpal osteotomies • Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.

Source page: https://510kreport.com/device/K163440
Methodology: https://510kreport.com/methodology