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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 / July 2026 / K260624

510(k) cleared

Arthrex Radial Head Replacement System

Arthrex, Inc. · Jul 30, 2026 · K260624

FDA cleared the Arthrex Radial Head Replacement System from Arthrex, Inc. on Jul 30, 2026 under K260624, a traditional 510(k). The device falls under product code KWI, Prosthesis, Elbow, Hemi-, Radial, Polymer, regulated at 21 CFR 888.3170 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 26, 2026. The decision came 154 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 K260624?

K260624 is the FDA 510(k) for Arthrex Radial Head Replacement System, submitted by Arthrex, Inc.. FDA's decision date was Jul 30, 2026, under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer).

Who makes the Arthrex Radial Head Replacement System?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K260624.

How long did the K260624 review take?

FDA received the submission on Feb 26, 2026 and issued its decision on Jul 30, 2026, 154 days later.

← All decisions in July 2026