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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 / K254198

510(k) cleared

Trexo Theo

Trexo Robotics, Inc. · Sep 2, 2026 · K254198 · In the directory

FDA cleared the Trexo Theo from Trexo Robotics, Inc. on Sep 2, 2026 under K254198, a traditional 510(k). The device falls under product code PHL, Powered Exoskeleton, regulated at 21 CFR 890.3480 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Dec 23, 2025. The decision came 253 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 Trexo Robotics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254198?

K254198 is the FDA 510(k) for Trexo Theo, submitted by Trexo Robotics, Inc.. FDA's decision date was Sep 2, 2026, under product code PHL (Powered Exoskeleton).

Who makes the Trexo Theo?

Trexo Robotics, Inc., based in Mississauga, is the applicant of record for K254198. The company is listed in the MedDevice Startups directory.

How long did the K254198 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Sep 2, 2026, 253 days later.

← All decisions in September 2026

Sources

In the startup directory

Trexo Robotics

Rehab & Mobility · Toronto, ON, Canada