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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 / K262451

510(k) cleared

Arthrex DynaNite Staples

Arthrex, Inc. · Sep 1, 2026 · K262451

FDA cleared the Arthrex DynaNite Staples from Arthrex, Inc. on Sep 1, 2026 under K262451, a traditional 510(k). The device falls under product code JDR, Staple, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 17, 2026. The decision came 46 days later, inside the 90 FDA-day goal for a 510(k).

Arthrex, Inc. has 8 other decisions in the tracker over the last 12 months: K262357 (Arthrex Bioabsorbable PushLock Suture Anchors), K260624 (Arthrex Radial Head Replacement System), K260018 (Arthrex FiberButton), K260809 (Arthrex Sterile VAL and VAL KreuLock Compression Screw System).

Questions & Answers

What did FDA clear under K262451?

K262451 is the FDA 510(k) for Arthrex DynaNite Staples, submitted by Arthrex, Inc.. FDA's decision date was Sep 1, 2026, under product code JDR (Staple, Fixation, Bone).

Who makes the Arthrex DynaNite Staples?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K262451.

How long did the K262451 review take?

FDA received the submission on Jul 17, 2026 and issued its decision on Sep 1, 2026, 46 days later.

← All decisions in September 2026