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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 / September 2026 / K262649

510(k) cleared

Alians Forearm

Newclip Technics · Sep 28, 2026 · K262649

FDA cleared the Alians Forearm from Newclip Technics on Sep 28, 2026 under K262649, 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 Jul 30, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Newclip Technics has 4 other decisions in the tracker over the last 12 months: K261511 (Xpert Ankle), K261191 (Alians Elbow S), K261038 (Xpert PFP), K253906 (Xpert Hand).

Questions & Answers

What did FDA clear under K262649?

K262649 is the FDA 510(k) for Alians Forearm, submitted by Newclip Technics. FDA's decision date was Sep 28, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Alians Forearm?

Newclip Technics, based in Haute-Goulaine, is the applicant of record for K262649.

How long did the K262649 review take?

FDA received the submission on Jul 30, 2026 and issued its decision on Sep 28, 2026, 60 days later.

← All decisions in September 2026

Sources