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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 / June 2026 / K260480

510(k) cleared

VELYS Robotic-Assisted Solution

Depuy Ireland UC · Jun 25, 2026 · K260480

FDA cleared the VELYS Robotic-Assisted Solution from Depuy Ireland UC on Jun 25, 2026 under K260480, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 13, 2026. The decision came 132 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Depuy Ireland UC has 5 other decisions in the tracker over the last 12 months: K261458 (ATTUNE Total Knee System; ATTUNE Cementless Knee System), K260536 (Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement), K253624 (INHANCE Reverse Shoulder System), K253551 (VELYS Hip Navigation).

Questions & Answers

What did FDA clear under K260480?

K260480 is the FDA 510(k) for VELYS Robotic-Assisted Solution, submitted by Depuy Ireland UC. FDA's decision date was Jun 25, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the VELYS Robotic-Assisted Solution?

Depuy Ireland UC, based in Ringaskiddy, Co. Cork, is the applicant of record for K260480.

How long did the K260480 review take?

FDA received the submission on Feb 13, 2026 and issued its decision on Jun 25, 2026, 132 days later.

← All decisions in June 2026