# K220181: StealthFix Intraosseous Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions, Inc.
- Decided: Mar 22, 2022 after 60 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: 8 generations back to K915818 (1992). 51 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163440: Stealth Staple System, First Ray, LLC (2017) Summary page 4.

## Most influential descendants
- K232324: StealthFix Intraosseous Fixation System (2023), 0 descendants of its own

## Indications for use
The StealthFix Intraosseous Fixation 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/K220181
Methodology: https://510kreport.com/methodology