# K232324: StealthFix Intraosseous Fixation System

- Pathway: 510(k) (Special)
- Applicant: Medartis, Inc.
- Decided: Aug 30, 2023 after 27 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: 9 generations back to K915818 (1992). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220181: StealthFix Intraosseous Fixation System, Nextremity Solutions, Inc. (2022) Summary page 4.

## 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/K232324
Methodology: https://510kreport.com/methodology