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FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K262193

510(k) cleared

RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology

Xenix Medical · Sep 14, 2026 · K262193 · In the directory

FDA cleared the RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology from Xenix Medical on Sep 14, 2026 under K262193, a traditional 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 Jun 29, 2026. The decision came 77 days later, inside the 90 FDA-day goal for a 510(k).

Xenix Medical has one other decision in the tracker over the last 12 months: K253583 (LUX Expandable Lumbar Interbody System).

Questions & Answers

What did FDA clear under K262193?

K262193 is the FDA 510(k) for RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology, submitted by Xenix Medical. FDA's decision date was Sep 14, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology?

Xenix Medical, based in Orlando, FL, is the applicant of record for K262193. The company is listed in the MedDevice Startups directory.

How long did the K262193 review take?

FDA received the submission on Jun 29, 2026 and issued its decision on Sep 14, 2026, 77 days later.

← All decisions in September 2026

Sources

In the startup directory

Xenix Medical

Orthopedics & Spine · Orlando, FL