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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 / January 2026 / K252807

510(k) cleared

Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates

Arthrex, Inc. · Jan 12, 2026 · K252807

FDA cleared the Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates from Arthrex, Inc. on Jan 12, 2026 under K252807, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 3, 2025. The decision came 131 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 K252807?

K252807 is the FDA 510(k) for Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates, submitted by Arthrex, Inc.. FDA's decision date was Jan 12, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K252807.

How long did the K252807 review take?

FDA received the submission on Sep 3, 2025 and issued its decision on Jan 12, 2026, 131 days later.

← All decisions in January 2026