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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

The Tracker / August 2026 / K262722

510(k) cleared

Primal K-Wire (P99-193-1410)

Paragon 28, Inc. · Aug 28, 2026 · K262722

FDA cleared the Primal K-Wire (P99-193-1410) from Paragon 28, Inc. on Aug 28, 2026 under K262722, a special 510(k). The device falls under product code HTY, Pin, Fixation, Smooth, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 31, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Paragon 28, Inc. has 6 other decisions in the tracker over the last 12 months: K261121 (Megalodon Dynamic Compression System), K262047 (Grappler Suture Anchor System), K253886 (Grappler Suture Anchor PCFD Tether System), K253591 (Phantom® Hindfoot TTC/TC Nail System).

Questions & Answers

What did FDA clear under K262722?

K262722 is the FDA 510(k) for Primal K-Wire (P99-193-1410), submitted by Paragon 28, Inc.. FDA's decision date was Aug 28, 2026, under product code HTY (Pin, Fixation, Smooth).

Who makes the Primal K-Wire (P99-193-1410)?

Paragon 28, Inc., based in Centennial, CO, is the applicant of record for K262722.

How long did the K262722 review take?

FDA received the submission on Jul 31, 2026 and issued its decision on Aug 28, 2026, 28 days later.

← All decisions in August 2026