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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 / June 2026 / K260809

510(k) cleared

Arthrex Sterile VAL and VAL KreuLock Compression Screw System

Arthrex, Inc. · Jun 25, 2026 · K260809

FDA cleared the Arthrex Sterile VAL and VAL KreuLock Compression Screw System from Arthrex, Inc. on Jun 25, 2026 under K260809, a traditional 510(k). The device falls under product code HWC, Screw, Fixation, Bone, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 12, 2026. The decision came 105 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 K260809?

K260809 is the FDA 510(k) for Arthrex Sterile VAL and VAL KreuLock Compression Screw System, submitted by Arthrex, Inc.. FDA's decision date was Jun 25, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the Arthrex Sterile VAL and VAL KreuLock Compression Screw System?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K260809.

How long did the K260809 review take?

FDA received the submission on Mar 12, 2026 and issued its decision on Jun 25, 2026, 105 days later.

← All decisions in June 2026