# K243357: CastleLoc Pectus Bar System

- Pathway: 510(k) (Traditional)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Feb 27, 2025 after 121 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: 14 generations back to K761228 (1976). 107 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 110 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.
- K241709: Pectus Blu Support Bar System, Biomet Microfixation (2024) Summary page 5.
- K221938: KLS Martin Pure Pectus System, KLS Martin L.P. (2023) Summary page 5.

## Most influential descendants
- K250892: CastleLoc Pectus Bar System (2025), 1 descendant of its own
- K260448: CastleLoc Pectus Bar System (2026), 0 descendants of its own

## Indications for use
The CastleLoc Pectus Bar System is indicated for the treatment of Pectus Excavatum and other anterior chest deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.

Source page: https://510kreport.com/device/K243357
Methodology: https://510kreport.com/methodology