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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K261189

510(k) cleared

Freedom Nail Ankle Fusion System

McGinley Orthopaedic Innovations · Oct 19, 2026 · K261189

FDA cleared the Freedom Nail Ankle Fusion System from McGinley Orthopaedic Innovations on Oct 19, 2026 under K261189, a traditional 510(k). The device falls under product code HSB, Rod, Fixation, Intramedullary And Accessories, regulated at 21 CFR 888.3020 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 10, 2026. The decision came 192 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 McGinley Orthopaedic Innovations in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261189?

K261189 is the FDA 510(k) for Freedom Nail Ankle Fusion System, submitted by McGinley Orthopaedic Innovations. FDA's decision date was Oct 19, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the Freedom Nail Ankle Fusion System?

McGinley Orthopaedic Innovations, based in Casper, WY, is the applicant of record for K261189.

How long did the K261189 review take?

FDA received the submission on Apr 10, 2026 and issued its decision on Oct 19, 2026, 192 days later.

← All decisions in October 2026