# K252019: CurvaFix Low Profile System

- Pathway: 510(k) (Traditional)
- Applicant: Curvafix, Inc.
- Decided: Aug 29, 2025 after 60 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: 15 generations back to K962616 (1996). 237 ancestors in all.
No later device cites it as a predicate yet.
0 of 238 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222505: CurvaFix IM System, Curvafix, Inc. (2022) Summary page 5.
- K180050: CurvaFix Intramedullary Rodscrew System, Curvafix, Inc. (2019) Summary page 5.
- K213126: Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws, Smith & Nephew, Inc. (2022) Summary page 5.

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

Source page: https://510kreport.com/device/K252019
Methodology: https://510kreport.com/methodology