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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 / 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: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

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