# K250620: KLS Martin Ixos System

- Pathway: 510(k) (Traditional)
- Applicant: KLS Martin L.P.
- Decided: Aug 15, 2025 after 168 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 K792022 (1979). 146 ancestors in all.
No later device cites it as a predicate yet.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222624: KLS Martin LINOS Wrist System, KLS-Martin L.P. (2023) Summary page 5.
- K212581: VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System, Stryker GmbH (2022) Summary page 5.

## Indications for use
The KLS Martin lxos system is indicated for use in forearm fractures, osteotomies, and arthrodeses. This system is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

Source page: https://510kreport.com/device/K250620
Methodology: https://510kreport.com/methodology