# K180050: CurvaFix Intramedullary Rodscrew System

- Pathway: 510(k) (Traditional)
- Applicant: Curvafix, Inc.
- Decided: Mar 1, 2019 after 417 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K043185 (2005). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 4.

## Most influential descendants
- K222505: CurvaFix IM System (2022), 1 descendant of its own
- K252019: CurvaFix Low Profile System (2025), 0 descendants of its own
- K200295: IlluminOss Bone Stabilization System (2020), 0 descendants of its own

## Indications for use
The CurvaFix® Intramedullary Rodscrew is intended for fixation of fractures of the pelvis.

Source page: https://510kreport.com/device/K180050
Methodology: https://510kreport.com/methodology