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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 / April 2026 / K260054

510(k) cleared

I.T.S. PRS Phoenix II

I.T.S. GmbH · Apr 24, 2026 · K260054

FDA cleared the I.T.S. PRS Phoenix II from I.T.S. GmbH on Apr 24, 2026 under K260054, 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 Jan 8, 2026. The decision came 106 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

I.T.S. GmbH has 8 other decisions in the tracker over the last 12 months: K261217 (AnyPlus II Spinal Fixation System), K254302 (ECG Analysis Software (AiTiALVSD)), K260250 (QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)).

Questions & Answers

What did FDA clear under K260054?

K260054 is the FDA 510(k) for I.T.S. PRS Phoenix II, submitted by I.T.S. GmbH. FDA's decision date was Apr 24, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the I.T.S. PRS Phoenix II?

I.T.S. GmbH, based in Laßnitzhöhe, is the applicant of record for K260054.

How long did the K260054 review take?

FDA received the submission on Jan 8, 2026 and issued its decision on Apr 24, 2026, 106 days later.

← All decisions in April 2026