# K221938: KLS Martin Pure Pectus System

- Pathway: 510(k) (Traditional)
- Applicant: KLS Martin L.P.
- Decided: Mar 28, 2023 after 270 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: 13 generations back to K761228 (1976). 103 ancestors in all.
6 later devices descend from it; 4 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)
- K972420: Lorenz Pectus Support Bar, Walter Lorenz Surgical, Inc. (1997) Summary page 4.
- K153482: KLS Martin Thoracic Plating System, KLS-Martin L.P. (2016) Summary page 4.

## Most influential descendants
- K243357: CastleLoc Pectus Bar System (2025), 2 descendants of its own
- K250892: CastleLoc Pectus Bar System (2025), 1 descendant of its own
- K241018: KLS Martin Orthopedic Implants - MR Conditional (2024), 1 descendant of its own
- K260448: CastleLoc Pectus Bar System (2026), 0 descendants of its own
- K253660: KLS Martin Pure Pectus System (2026), 0 descendants of its own

## 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/K221938
Methodology: https://510kreport.com/methodology