# K153622: First Ray Internal Bone Staple System

- Pathway: 510(k) (Traditional)
- Applicant: First Ray, LLC
- Decided: Apr 8, 2016 after 112 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: 3 generations back to K964226 (1997). 8 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011716: The Uni-Clip Staple, New Deal, S.A. (2001) Summary page 5.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 5.
- (no number) Richards Staple (pre-amendment): named in the summary without a submission number

## Most influential descendants
- K163440: Stealth Staple System (2017), 3 descendants of its own
- 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 First Ray Internal Bone 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/K153622
Methodology: https://510kreport.com/methodology