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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 / November 2025 / K250865

510(k) cleared

KLS Martin IPS Forearm System

KLS-Martin L.P. · Nov 14, 2025 · K250865

FDA cleared the KLS Martin IPS Forearm System from KLS-Martin L.P. on Nov 14, 2025 under K250865, 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 Mar 21, 2025. The decision came 238 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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), K254162 (KLS Martin Ixos System), K250988 (KLS Martin Pure Pectus System).

Questions & Answers

What did FDA clear under K250865?

K250865 is the FDA 510(k) for KLS Martin IPS Forearm System, submitted by KLS-Martin L.P.. FDA's decision date was Nov 14, 2025, under product code HRS (Plate, Fixation, Bone).

Who makes the KLS Martin IPS Forearm System?

KLS-Martin L.P., based in Jacksonville, FL, is the applicant of record for K250865.

How long did the K250865 review take?

FDA received the submission on Mar 21, 2025 and issued its decision on Nov 14, 2025, 238 days later.

← All decisions in November 2025