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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K262130

510(k) cleared

ATTUNE Revision Knee System

Depuy Orthopaedics, Inc. · Sep 4, 2026 · K262130

FDA cleared the ATTUNE Revision Knee System from Depuy Orthopaedics, Inc. on Sep 4, 2026 under K262130, 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 Jun 24, 2026. The decision came 72 days later, inside the 90 FDA-day goal for a 510(k).

Depuy Orthopaedics, Inc. has one other decision in the tracker over the last 12 months: K252887 (DePuy ATTUNE Knee System).

Questions & Answers

What did FDA clear under K262130?

K262130 is the FDA 510(k) for ATTUNE Revision Knee System, submitted by Depuy Orthopaedics, Inc.. FDA's decision date was Sep 4, 2026, under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

Who makes the ATTUNE Revision Knee System?

Depuy Orthopaedics, Inc., based in Warsaw, IN, is the applicant of record for K262130.

How long did the K262130 review take?

FDA received the submission on Jun 24, 2026 and issued its decision on Sep 4, 2026, 72 days later.

← All decisions in September 2026

Sources