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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 / June 2026 / K261016

510(k) cleared

MSS - Humeral reverse liners extension

Medacta International, SA · Jun 10, 2026 · K261016

FDA cleared the MSS - Humeral reverse liners extension from Medacta International, SA on Jun 10, 2026 under K261016, a traditional 510(k). The device falls under product code PHX, Shoulder Prosthesis, Reverse Configuration, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 27, 2026. The decision came 75 days later, inside the 90 FDA-day goal for a 510(k).

Medacta International, SA has 8 other decisions in the tracker over the last 12 months: K254202 (MectaLIF 3D Metal Anterior), 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 K261016?

K261016 is the FDA 510(k) for MSS - Humeral reverse liners extension, submitted by Medacta International, SA. FDA's decision date was Jun 10, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the MSS - Humeral reverse liners extension?

Medacta International, SA, based in Castel San Pietro, is the applicant of record for K261016.

How long did the K261016 review take?

FDA received the submission on Mar 27, 2026 and issued its decision on Jun 10, 2026, 75 days later.

← All decisions in June 2026