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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 / November 2025 / K253197

510(k) cleared

ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors

Depuy Ireland UC · Nov 19, 2025 · K253197

FDA cleared the ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors from Depuy Ireland UC on Nov 19, 2025 under K253197, 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 Sep 26, 2025. The decision came 54 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), K260536 (Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement), K253624 (INHANCE Reverse Shoulder System).

Questions & Answers

What did FDA clear under K253197?

K253197 is the FDA 510(k) for ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors, submitted by Depuy Ireland UC. FDA's decision date was Nov 19, 2025, under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

Who makes the ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors?

Depuy Ireland UC, based in Ringaskiddy, is the applicant of record for K253197.

How long did the K253197 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Nov 19, 2025, 54 days later.

← All decisions in November 2025

Sources