WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / March 2026 / K253551

510(k) cleared

VELYS Hip Navigation

Depuy Ireland UC · Mar 6, 2026 · K253551

FDA cleared the VELYS Hip Navigation from Depuy Ireland UC on Mar 6, 2026 under K253551, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 14, 2025. The decision came 112 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: K260480 (VELYS Robotic-Assisted Solution), 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).

Questions & Answers

What did FDA clear under K253551?

K253551 is the FDA 510(k) for VELYS Hip Navigation, submitted by Depuy Ireland UC. FDA's decision date was Mar 6, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the VELYS Hip Navigation?

Depuy Ireland UC, based in Ringaskiddy, Co. Cork, is the applicant of record for K253551.

How long did the K253551 review take?

FDA received the submission on Nov 14, 2025 and issued its decision on Mar 6, 2026, 112 days later.

← All decisions in March 2026