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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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.

DePuy Orthopaedics, Inc. has one other decision in the tracker over the last 12 months: K262130 (ATTUNE Revision Knee System).

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

Sources