# K200226: RetroFix

- Pathway: 510(k) (Traditional)
- Applicant: Retrofix Screws, LLC
- Decided: Jun 26, 2020 after 148 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: 13 generations back to K962616 (1996). 157 ancestors in all.
No later device cites it as a predicate yet.
0 of 158 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172383: Arthrosurface Bone Screws, Arthrosurface, Inc. (2017) Summary page 6.

## Indications for use
The RetroFix screw is a cannulated tapered screw intended to be used as stand-alone bone screw for internal bone fixation for bone fractures of the ankle.

Source page: https://510kreport.com/device/K200226
Methodology: https://510kreport.com/methodology