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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 / K262828

510(k) cleared

KHEIRON® Spinal Fixation System, including patient specific K-ROD

S.M.A.I.O · Sep 4, 2026 · K262828

FDA cleared the KHEIRON® Spinal Fixation System, including patient specific K-ROD from S.M.A.I.O on Sep 4, 2026 under K262828, a special 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 10, 2026. The decision came 25 days later, inside the 90 FDA-day goal for a 510(k).

S.M.A.I.O has 8 other decisions in the tracker over the last 12 months: DEN250043 (Qoramatic Automated Stool Management), K261500 (KBA3D (v2.4.0)), K253808 (AIR Recon DL), K253667 (Accoat Guide Wire).

Questions & Answers

What did FDA clear under K262828?

K262828 is the FDA 510(k) for KHEIRON® Spinal Fixation System, including patient specific K-ROD, submitted by S.M.A.I.O. FDA's decision date was Sep 4, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the KHEIRON® Spinal Fixation System, including patient specific K-ROD?

S.M.A.I.O, based in Saint-Priest, is the applicant of record for K262828.

How long did the K262828 review take?

FDA received the submission on Aug 10, 2026 and issued its decision on Sep 4, 2026, 25 days later.

← All decisions in September 2026