WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

510(k)

Xenix Medical clears the Riva Anchor for sacroiliac fusion at the base of a lumbar construct

MedDevice Startups Staff · 23 hrs ago · 2 min read · Via BioSpace

FDA cleared Xenix Medical's Riva Anchor Spinopelvic Fixation System on September 22. The implant fuses the sacroiliac joint at the base of a posterior lumbar or thoracolumbar construct.

The Orlando company built it as a dual lead, fully threaded implant with self-harvesting bone apertures, sized for 5.5mm and 6.0mm rods. Surgeons can place it open, under fluoroscopy or with navigation. The surface is Xenix's NanoACTIV texture, which the company says FDA has designated as having an osteogenic effect. Riva Anchor follows two other Xenix clearances this year, the Riva Posterior Fixation System in June and the Lux expandable lumbar interbody cage days later. A limited commercial launch comes first.

Questions & Answers

What is the Xenix Medical Riva Anchor Spinopelvic Fixation System?

It is a sacroiliac joint fixation implant that attaches at the base of a posterior lumbar or thoracolumbar fusion construct. FDA cleared it on September 22, 2026.

What is NanoACTIV surface technology?

NanoACTIV is Xenix Medical's proprietary micro and nano scale implant surface texture. Xenix says the Riva Anchor is the only spinopelvic system FDA has designated as having an osteogenic effect.

When will the Xenix Medical Riva Anchor be available?

Xenix Medical, based in Orlando, Florida, said it is preparing a limited commercial launch. The company has not given a date for full availability.

← Back to Newly Cleared