# K222397: KLS Martin Level One Rib Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Mar 29, 2023 after 233 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). 104 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153482: KLS Martin Thoracic Plating System, KLS-Martin L.P. (2016)
- K151983: KLS Martin LSS Plating System, KLS Martin L.P. (2016)

## Most influential descendants
- K241018: KLS Martin Orthopedic Implants - MR Conditional (2024), 1 descendant of its own
- K261892: ProRib Fixation System (2026), 0 descendants of its own
- K250988: KLS Martin Pure Pectus System (2025), 0 descendants of its own

## Indications for use
The KLS Martin Level One Rib Fixation System is indicated for use in the stabilization and rigid fixation of rib fractures in the chest wall including reconstructive procedures, trauma, or planned osteotomies in patients 18 years of age or older.

Source page: https://510kreport.com/device/K222397
Methodology: https://510kreport.com/methodology