# K251050: Pectus Versa System

- Pathway: 510(k) (Traditional)
- Applicant: Gm Dos Reis Industria E Comercio
- Decided: Dec 19, 2025 after 260 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: 4 generations back to K972420 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191057: Park's Pectus System, Tdm Co., Ltd. (2020) Summary page 5.
- K213712: Pectus Support Bar System, Biomet Microfixation (2022) Summary page 5.

## Indications for use
The Pectus Versa System is indicated for the treatment of Pectus Excavatum and other anterior chest wall deformities in adult and pediatric patients (children and adolescents).

Source page: https://510kreport.com/device/K251050
Methodology: https://510kreport.com/methodology