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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 / K261458

510(k) cleared

ATTUNE Total Knee System; ATTUNE Cementless Knee System

DePuy Ireland UC · Jun 25, 2026 · K261458

FDA cleared the ATTUNE Total Knee System; ATTUNE Cementless Knee System from DePuy Ireland UC on Jun 25, 2026 under K261458, a traditional 510(k). The device falls under product code JWH, Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, regulated at 21 CFR 888.3560 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on May 1, 2026. The decision came 55 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), 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 K261458?

K261458 is the FDA 510(k) for ATTUNE Total Knee System; ATTUNE Cementless Knee System, submitted by DePuy Ireland UC. FDA's decision date was Jun 25, 2026, under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

Who makes the ATTUNE Total Knee System; ATTUNE Cementless Knee System?

DePuy Ireland UC, based in Cork, is the applicant of record for K261458.

How long did the K261458 review take?

FDA received the submission on May 1, 2026 and issued its decision on Jun 25, 2026, 55 days later.

← All decisions in June 2026

Sources