# K254162: KLS Martin Ixos System

- Pathway: 510(k) (Traditional)
- Applicant: KLS Martin L.P.
- Decided: Feb 20, 2026 after 60 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: 10 generations back to K000684 (2000). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 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 6.
- K143749: Arthrex Distal Radius System, Arthrex, Inc. (2015)
- K092247: Synthes Locking Hand Plates, Synthes (Usa) (2009) 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/K254162
Methodology: https://510kreport.com/methodology