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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 / October 2026 / K260913

510(k) cleared

CMF Titanium Splints

Materialise NV · Oct 9, 2026 · K260913

FDA cleared the CMF Titanium Splints from Materialise NV on Oct 9, 2026 under K260913, a traditional 510(k). The device falls under product code DZJ, Driver, Wire, And Bone Drill, Manual, regulated at 21 CFR 872.4120 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Mar 19, 2026. The decision came 204 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Materialise NV has 4 other decisions in the tracker over the last 12 months: K260802 (Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner), K251964 (Mimics Thoracic Planner), K253308 (Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models), K253793 (Materialise TKA Guide System).

Questions & Answers

What did FDA clear under K260913?

K260913 is the FDA 510(k) for CMF Titanium Splints, submitted by Materialise NV. FDA's decision date was Oct 9, 2026, under product code DZJ (Driver, Wire, And Bone Drill, Manual).

Who makes the CMF Titanium Splints?

Materialise NV, based in Leuven, is the applicant of record for K260913.

How long did the K260913 review take?

FDA received the submission on Mar 19, 2026 and issued its decision on Oct 9, 2026, 204 days later.

← All decisions in October 2026