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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 / April 2026 / K252404

510(k) cleared

Comprehensive Reverse Shoulder - HA Glenosphere Baseplates

Biomet Orthopedics · Apr 15, 2026 · K252404

FDA cleared the Comprehensive Reverse Shoulder - HA Glenosphere Baseplates from Biomet Orthopedics on Apr 15, 2026 under K252404, a traditional 510(k). The device falls under product code PHX, Shoulder Prosthesis, Reverse Configuration, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 31, 2025. The decision came 258 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Biomet Orthopedics has one other decision in the tracker over the last 12 months: K253515 (Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments).

Questions & Answers

What did FDA clear under K252404?

K252404 is the FDA 510(k) for Comprehensive Reverse Shoulder - HA Glenosphere Baseplates, submitted by Biomet Orthopedics. FDA's decision date was Apr 15, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the Comprehensive Reverse Shoulder - HA Glenosphere Baseplates?

Biomet Orthopedics, based in Warsaw, IN, is the applicant of record for K252404.

How long did the K252404 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on Apr 15, 2026, 258 days later.

← All decisions in April 2026

Sources