WHERE ARE YOU?

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

THE TAPE

Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

510(k)

Bioretec clears a headless bioabsorbable compression screw for hand and foot fixation

MedDevice Startups Staff · 1 day ago · 2 min read · Via Ortho Spine News

FDA cleared Bioretec's ActivaScrew Cannulated COM on September 8. The headless screw is made from self-reinforced PLGA and is indicated for fixation of bone and osteochondral fractures, osteotomies, arthrodeses and bone grafts in the hand, the non-diaphyseal arm and forearm, the foot and the non-diaphyseal ankle, in skeletally mature patients with appropriate immobilization.

The Finnish company already sells the ActivaScrew line and says more than 500,000 Activa implants have been distributed. CEO Sarah van Hellenberg Hubar-Fisher said the headless design matches what US surgeons prefer, and called the clearance part of the 2026 commercialization plan.

The indication statement is worth reading closely if you are drafting your own. Every anatomic site is enumerated and the diaphysis is carved out twice. That is what a predicate-driven orthopedic clearance looks like when the sponsor keeps the claim narrow enough to avoid new bench or clinical data.

Questions & Answers

What is the Bioretec ActivaScrew Cannulated COM?

ActivaScrew Cannulated COM is a headless bioabsorbable compression screw from Bioretec made of self-reinforced PLGA. The FDA cleared it through the 510(k) pathway on September 8, 2026.

What is the cleared indication for Bioretec's ActivaScrew Cannulated COM?

It is indicated for fixation of bone and osteochondral fractures, osteotomies, arthrodeses and bone grafts in the hand, the non-diaphyseal arm and forearm, the foot and the non-diaphyseal ankle in skeletally mature patients, with appropriate immobilization.

Where is Bioretec based and what else does it sell?

Bioretec is a Finnish orthopedic implant maker. Alongside the ActivaScrew bioabsorbable line, it sells the RemeOs magnesium alloy implants, and it says more than 500,000 Activa implants have been distributed to date.

← Back to Newly Cleared