# K260411: PC Fix System

- Pathway: 510(k) (Traditional)
- Applicant: Chest Wall Innovations, Inc.
- Decided: Apr 24, 2026 after 74 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: 8 generations back to K000684 (2000). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203474: Biomet Microfixation RibFix Advantage System, Biomet Micofixation (2021) Summary page 5.

## Indications for use
The PC Fix System is indicated for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

Source page: https://510kreport.com/device/K260411
Methodology: https://510kreport.com/methodology