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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 / May 2026 / K260536

510(k) cleared

Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement

Depuy Ireland UC · May 15, 2026 · K260536

FDA cleared the Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement from Depuy Ireland UC on May 15, 2026 under K260536, a traditional 510(k). The device falls under product code KWL, Prosthesis, Hip, Hemi-, Femoral, Metal, regulated at 21 CFR 888.3360 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 17, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

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), K253624 (INHANCE Reverse Shoulder System), K253551 (VELYS Hip Navigation).

Questions & Answers

What did FDA clear under K260536?

K260536 is the FDA 510(k) for Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement, submitted by Depuy Ireland UC. FDA's decision date was May 15, 2026, under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal).

Who makes the Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement?

Depuy Ireland UC, based in Ringaskiddy, is the applicant of record for K260536.

How long did the K260536 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on May 15, 2026, 87 days later.

← All decisions in May 2026