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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 / May 2026 / K254202

510(k) cleared

MectaLIF 3D Metal Anterior

Medacta International S.A. · May 5, 2026 · K254202

FDA cleared the MectaLIF 3D Metal Anterior from Medacta International S.A. on May 5, 2026 under K254202, a traditional 510(k). The device falls under product code OVD, Intervertebral Fusion Device With Integrated Fixation, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 29, 2025. The decision came 127 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medacta International S.A. has 8 other decisions in the tracker over the last 12 months: K260173 (M-Vizion Femoral Revision System Extension), K262057 (GMK Extension), K253630 (Mpact 3D Metal Foam), K261016 (MSS - Humeral reverse liners extension).

Questions & Answers

What did FDA clear under K254202?

K254202 is the FDA 510(k) for MectaLIF 3D Metal Anterior, submitted by Medacta International S.A.. FDA's decision date was May 5, 2026, under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar).

Who makes the MectaLIF 3D Metal Anterior?

Medacta International S.A., based in Castel San Pietro, is the applicant of record for K254202.

How long did the K254202 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on May 5, 2026, 127 days later.

← All decisions in May 2026