# K242055: Freefix Forearm Plating System

- Pathway: 510(k) (Special)
- Applicant: Skeletal Dynamics, Inc.
- Decided: Aug 1, 2024 after 17 days
- Product code: HRS (Plate, 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 K962616 (1996). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200538: Skeletal Dynamics Forearm Plating System, Skeletal Dynamics, Inc. (2020) Summary page 4.

## Indications for use
The FreeFix Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.

Source page: https://510kreport.com/device/K242055
Methodology: https://510kreport.com/methodology