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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 / March 2026 / K260561

510(k) cleared

Arthrex FiberTak Suture Anchor

Arthrex, Inc. · Mar 20, 2026 · K260561

FDA cleared the Arthrex FiberTak Suture Anchor from Arthrex, Inc. on Mar 20, 2026 under K260561, a special 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 19, 2026. The decision came 29 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 K260561?

K260561 is the FDA 510(k) for Arthrex FiberTak Suture Anchor, submitted by Arthrex, Inc.. FDA's decision date was Mar 20, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Arthrex FiberTak Suture Anchor?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K260561.

How long did the K260561 review take?

FDA received the submission on Feb 19, 2026 and issued its decision on Mar 20, 2026, 29 days later.

← All decisions in March 2026