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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 / K253065

510(k) cleared

Aevumed SUPERCYNCH Button System

Aevumed, Inc. · Sep 2, 2026 · K253065

FDA cleared the Aevumed SUPERCYNCH Button System from Aevumed, Inc. on Sep 2, 2026 under K253065, a traditional 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 22, 2025. The decision came 345 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Aevumed, Inc. has 3 other decisions in the tracker over the last 12 months: K254306 (Aevumed FENIX Suture Anchor), K260004 (Aevumed PROTEKT Suture Anchor), K253040 (Aevumed FASE Suture Anchor).

Questions & Answers

What did FDA clear under K253065?

K253065 is the FDA 510(k) for Aevumed SUPERCYNCH Button System, submitted by Aevumed, Inc.. FDA's decision date was Sep 2, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Aevumed SUPERCYNCH Button System?

Aevumed, Inc., based in Malvern, PA, is the applicant of record for K253065.

How long did the K253065 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Sep 2, 2026, 345 days later.

← All decisions in September 2026

Sources