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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 / July 2026 / K261968

510(k) cleared

Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)

Smith & Nephew, Inc. · Jul 9, 2026 · K261968

FDA cleared the Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) from Smith & Nephew, Inc. on Jul 9, 2026 under K261968, 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 Jun 11, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Smith & Nephew, Inc. has 6 other decisions in the tracker over the last 12 months: K261338 (RENASYS DYNAFLOW Kit (66807741)), K261462 (LANDMARK Total Knee System), DEN250037 (TESSA Spatial Surgery System; INTELLIO Tablet (72205455)), K260646 (RENASYS EDGE (66803126)).

Questions & Answers

What did FDA clear under K261968?

K261968 is the FDA 510(k) for Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982), submitted by Smith & Nephew, Inc.. FDA's decision date was Jul 9, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)?

Smith & Nephew, Inc., based in Andover, MA, is the applicant of record for K261968.

How long did the K261968 review take?

FDA received the submission on Jun 11, 2026 and issued its decision on Jul 9, 2026, 28 days later.

← All decisions in July 2026