# K250988: KLS Martin Pure Pectus System

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Dec 11, 2025 after 255 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: 15 generations back to K761228 (1976). 137 ancestors in all.
No later device cites it as a predicate yet.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221938: KLS Martin Pure Pectus System, KLS Martin L.P. (2023) Summary page 6.
- K241018: KLS Martin Orthopedic Implants - MR Conditional, KLS-Martin L.P. (2024)

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

Source page: https://510kreport.com/device/K250988
Methodology: https://510kreport.com/methodology