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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K254162

510(k) cleared

KLS Martin Ixos System

KLS Martin L.P. · Feb 20, 2026 · K254162

FDA cleared the KLS Martin Ixos System from KLS Martin L.P. on Feb 20, 2026 under K254162, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 22, 2025. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

KLS Martin L.P. has 4 other decisions in the tracker over the last 12 months: K253660 (KLS Martin Pure Pectus System), K250988 (KLS Martin Pure Pectus System), K250865 (KLS Martin IPS Forearm System), K252573 (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).

Questions & Answers

What did FDA clear under K254162?

K254162 is the FDA 510(k) for KLS Martin Ixos System, submitted by KLS Martin L.P.. FDA's decision date was Feb 20, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the KLS Martin Ixos System?

KLS Martin L.P., based in Jacksonville, FL, is the applicant of record for K254162.

How long did the K254162 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on Feb 20, 2026, 60 days later.

← All decisions in February 2026