Cleared Traditional

KLS Martin Ixos System

K254162 · KLS-Martin L.P. · Orthopedic
Feb 2026
Decision
60d
Days
Risk

About This 510(k) Submission

K254162 is an FDA 510(k) clearance for the KLS Martin Ixos System, submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on February 20, 2026, 60 days after receiving the submission on December 22, 2025. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K254162 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2025
Decision Date February 20, 2026
Days to Decision 60 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code
Device Class

More from KLS-Martin L.P.

View all
KLS Martin Pure Pectus System
K253660 · HRS · Feb 2026
KLS Martin Pure Pectus System
K250988 · HRS · Dec 2025
KLS Martin IPS Forearm System
K250865 · HRS · Nov 2025
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
K252573 · GXN · Nov 2025
KLS Martin Ixos System
K250620 · HRS · Aug 2025