# K212841: Pectus Blu Support Bar System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Micofixation
- Decided: Jan 7, 2022 after 122 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.
5 later devices descend from it; 1 cites it directly.
0 of 9 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
- K241709: Pectus Blu Support Bar System (2024), 4 descendants of its own
- K243357: CastleLoc Pectus Bar System (2025), 2 descendants of its own
- K250892: CastleLoc Pectus Bar System (2025), 1 descendant of its own
- K261002: Pectus Blu System (2026), 0 descendants of its own
- K260448: CastleLoc Pectus Bar System (2026), 0 descendants of its own

## Indications for use
The Pectus Blu system is indicated for the treatment of Pectus Excavatum and other sternal deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.

Source page: https://510kreport.com/device/K212841
Methodology: https://510kreport.com/methodology