# K222505: CurvaFix IM System

- Pathway: 510(k) (Traditional)
- Applicant: Curvafix, Inc.
- Decided: Oct 27, 2022 after 70 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: 2 generations back to K043185 (2005). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180050: CurvaFix Intramedullary Rodscrew System, Curvafix, Inc. (2019) Summary page 4.
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 4.

## Most influential descendants
- K252019: CurvaFix Low Profile System (2025), 0 descendants of its own

## Indications for use
The CurvaFix® IM System is intended for fixation of fractures of the pelvis.

Source page: https://510kreport.com/device/K222505
Methodology: https://510kreport.com/methodology