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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 / November 2025 / K242603

510(k) cleared

MyPAO SA guides

Medacta International S.A. · Nov 19, 2025 · K242603

FDA cleared the MyPAO SA guides from Medacta International S.A. on Nov 19, 2025 under K242603, a traditional 510(k). The device falls under product code PBF, Orthopaedic Surgical Planning And Instrument Guides, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 30, 2024. The decision came 446 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), K253940 (M.U.S.T. Pedicle Screw System - Extension), K253328 (GMK 3D Metal Tibial Tray Extension).

Questions & Answers

What did FDA clear under K242603?

K242603 is the FDA 510(k) for MyPAO SA guides, submitted by Medacta International S.A.. FDA's decision date was Nov 19, 2025, under product code PBF (Orthopaedic Surgical Planning And Instrument Guides).

Who makes the MyPAO SA guides?

Medacta International S.A., based in Castel San Pietro, is the applicant of record for K242603.

How long did the K242603 review take?

FDA received the submission on Aug 30, 2024 and issued its decision on Nov 19, 2025, 446 days later.

← All decisions in November 2025