# K260448: CastleLoc Pectus Bar System

- Pathway: 510(k) (Special)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Mar 19, 2026 after 36 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: 16 generations back to K761228 (1976). 109 ancestors in all.
No later device cites it as a predicate yet.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250892: CastleLoc Pectus Bar System, L&K BIOMED Co., Ltd. (2025) Summary page 5.
- K243357: CastleLoc Pectus Bar System, L&K BIOMED Co., Ltd. (2025) Summary page 5.

## 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/K260448
Methodology: https://510kreport.com/methodology