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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 / December 2025 / K253895

510(k) cleared

Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm

Arthrex, Inc. · Dec 30, 2025 · K253895

FDA cleared the Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm from Arthrex, Inc. on Dec 30, 2025 under K253895, 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 Dec 4, 2025. The decision came 26 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 K253895?

K253895 is the FDA 510(k) for Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm, submitted by Arthrex, Inc.. FDA's decision date was Dec 30, 2025, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K253895.

How long did the K253895 review take?

FDA received the submission on Dec 4, 2025 and issued its decision on Dec 30, 2025, 26 days later.

← All decisions in December 2025