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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 / October 2026 / K262473

510(k) cleared

NEXUS® Hip Stem

Microport Orthopedics, Inc. · Oct 1, 2026 · K262473

FDA cleared the NEXUS® Hip Stem from Microport Orthopedics, Inc. on Oct 1, 2026 under K262473, a special 510(k). The device falls under product code LZO, Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, regulated at 21 CFR 888.3353 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 17, 2026. The decision came 76 days later, inside the 90 FDA-day goal for a 510(k).

Microport Orthopedics, Inc. has one other decision in the tracker over the last 12 months: K253728 (EVOLUTION® AM BIOFOAM® Tibial System).

Questions & Answers

What did FDA clear under K262473?

K262473 is the FDA 510(k) for NEXUS® Hip Stem, submitted by Microport Orthopedics, Inc.. FDA's decision date was Oct 1, 2026, under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented).

Who makes the NEXUS® Hip Stem?

Microport Orthopedics, Inc., based in Arlington, TN, is the applicant of record for K262473.

How long did the K262473 review take?

FDA received the submission on Jul 17, 2026 and issued its decision on Oct 1, 2026, 76 days later.

← All decisions in October 2026

Sources