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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 / K252887

510(k) cleared

DePuy ATTUNE Knee System

DePuy Orthopaedics, Inc. · May 22, 2026 · K252887

FDA cleared the DePuy ATTUNE Knee System from DePuy Orthopaedics, Inc. on May 22, 2026 under K252887, a traditional 510(k). The device falls under product code OIY, Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive, regulated at 21 CFR 888.3560 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 10, 2025. The decision came 254 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for DePuy Orthopaedics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252887?

K252887 is the FDA 510(k) for DePuy ATTUNE Knee System, submitted by DePuy Orthopaedics, Inc.. FDA's decision date was May 22, 2026, under product code OIY (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive).

Who makes the DePuy ATTUNE Knee System?

DePuy Orthopaedics, Inc., based in Warsaw, IN, is the applicant of record for K252887.

How long did the K252887 review take?

FDA received the submission on Sep 10, 2025 and issued its decision on May 22, 2026, 254 days later.

← All decisions in May 2026