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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / August 2026 / K261576

510(k) cleared

Icona Hip Stem

Corin, Ltd. · Aug 10, 2026 · K261576

FDA cleared the Icona Hip Stem from Corin, Ltd. on Aug 10, 2026 under K261576, a traditional 510(k). The device falls under product code MEH, Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, regulated at 21 CFR 888.3353 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on May 12, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Corin, Ltd. has one other decision in the tracker over the last 12 months: K261275 (Unity Total Knee System, Unity Knee Cementless CR Femur).

Questions & Answers

What did FDA clear under K261576?

K261576 is the FDA 510(k) for Icona Hip Stem, submitted by Corin, Ltd.. FDA's decision date was Aug 10, 2026, under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate).

Who makes the Icona Hip Stem?

Corin, Ltd., based in Cirencester, is the applicant of record for K261576.

How long did the K261576 review take?

FDA received the submission on May 12, 2026 and issued its decision on Aug 10, 2026, 90 days later.

← All decisions in August 2026

Sources