# K213712: Pectus Support Bar System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Microfixation
- Decided: Mar 11, 2022 after 107 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: 3 generations back to K972420 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061384: Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium, Walter Lorenz Surgical, Inc. (2006) Summary page 4.

## Most influential descendants
- K251050: Pectus Versa System (2025), 0 descendants of its own

## Indications for use
This device is intended for use in surgical procedures to repair Pectus Excavatum. It is intended to be used in pediatric (children and adolescents) populations.

Source page: https://510kreport.com/device/K213712
Methodology: https://510kreport.com/methodology