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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 / K261057

510(k) cleared

ActivaScrew Cannulated COM

Bioretec, Ltd. · Sep 4, 2026 · K261057

FDA cleared the ActivaScrew Cannulated COM from Bioretec, Ltd. on Sep 4, 2026 under K261057, a traditional 510(k). The device falls under product code HWC, Screw, Fixation, Bone, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 31, 2026. The decision came 157 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Bioretec, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261057?

K261057 is the FDA 510(k) for ActivaScrew Cannulated COM, submitted by Bioretec, Ltd.. FDA's decision date was Sep 4, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the ActivaScrew Cannulated COM?

Bioretec, Ltd., based in Tampere, is the applicant of record for K261057.

How long did the K261057 review take?

FDA received the submission on Mar 31, 2026 and issued its decision on Sep 4, 2026, 157 days later.

← All decisions in September 2026