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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 / K253713

510(k) cleared

Arthrex Variable Angle (VA) Proximal Tibia Plating System

Arthrex, Inc. · Jan 21, 2026 · K253713

FDA cleared the Arthrex Variable Angle (VA) Proximal Tibia Plating System from Arthrex, Inc. on Jan 21, 2026 under K253713, 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 Nov 24, 2025. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

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 K253713?

K253713 is the FDA 510(k) for Arthrex Variable Angle (VA) Proximal Tibia Plating System, submitted by Arthrex, Inc.. FDA's decision date was Jan 21, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Arthrex Variable Angle (VA) Proximal Tibia Plating System?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K253713.

How long did the K253713 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Jan 21, 2026, 58 days later.

← All decisions in January 2026