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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 / March 2026 / K252016

510(k) cleared

Arthrex Humeral Nails

Arthrex, Inc. · Mar 20, 2026 · K252016

FDA cleared the Arthrex Humeral Nails from Arthrex, Inc. on Mar 20, 2026 under K252016, 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 Jun 27, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Arthrex, Inc. has 8 other decisions in the tracker over the last 12 months: K262975 (Arthrex Beaming System), K262618 (Arthrex Spine Compression FT Screw), K262451 (Arthrex DynaNite Staples), K262357 (Arthrex Bioabsorbable PushLock Suture Anchors).

Questions & Answers

What did FDA clear under K252016?

K252016 is the FDA 510(k) for Arthrex Humeral Nails, submitted by Arthrex, Inc.. FDA's decision date was Mar 20, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the Arthrex Humeral Nails?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K252016.

How long did the K252016 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Mar 20, 2026, 266 days later.

← All decisions in March 2026