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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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: K261016 (MSS - Humeral reverse liners extension), K253940 (M.U.S.T. Pedicle Screw System - Extension), K253328 (GMK 3D Metal Tibial Tray Extension), K250644 (MSS - Monobloc stem).

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