# K253660: KLS Martin Pure Pectus System

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Feb 20, 2026 after 92 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). 104 ancestors in all.
No later device cites it as a predicate yet.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073556: Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos, Medxpert GmbH (2008) Summary page 5.
- K221938: KLS Martin Pure Pectus System, KLS Martin L.P. (2023) Summary page 6.

## Indications for use
The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum and other anterior chest wall deformities. It is indicated for use in adult and pediatric (children and adolescents) populations.

Source page: https://510kreport.com/device/K253660
Methodology: https://510kreport.com/methodology