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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 / April 2026 / K253940

510(k) cleared

M.U.S.T. Pedicle Screw System - Extension

Medacta International S.A. · Apr 28, 2026 · K253940

FDA cleared the M.U.S.T. Pedicle Screw System - Extension from Medacta International S.A. on Apr 28, 2026 under K253940, a traditional 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 9, 2025. The decision came 140 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), K254202 (MectaLIF 3D Metal Anterior), K253328 (GMK 3D Metal Tibial Tray Extension), K250644 (MSS - Monobloc stem).

Questions & Answers

What did FDA clear under K253940?

K253940 is the FDA 510(k) for M.U.S.T. Pedicle Screw System - Extension, submitted by Medacta International S.A.. FDA's decision date was Apr 28, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the M.U.S.T. Pedicle Screw System - Extension?

Medacta International S.A., based in Castel San Pietro, is the applicant of record for K253940.

How long did the K253940 review take?

FDA received the submission on Dec 9, 2025 and issued its decision on Apr 28, 2026, 140 days later.

← All decisions in April 2026