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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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 5 other decisions in the tracker over the last 12 months: K260137 (KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions), K253660 (KLS Martin Pure Pectus System), K250988 (KLS Martin Pure Pectus System), K250865 (KLS Martin IPS Forearm System).

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