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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 / October 2025 / K250338

510(k) cleared

MSS - Humeral reverse liners extension

Medacta International S.A. · Oct 31, 2025 · K250338

FDA cleared the MSS - Humeral reverse liners extension from Medacta International S.A. on Oct 31, 2025 under K250338, 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 Feb 6, 2025. The decision came 267 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 K250338?

K250338 is the FDA 510(k) for MSS - Humeral reverse liners extension, submitted by Medacta International S.A.. FDA's decision date was Oct 31, 2025, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the MSS - Humeral reverse liners extension?

Medacta International S.A., based in Castel San Pietro, is the applicant of record for K250338.

How long did the K250338 review take?

FDA received the submission on Feb 6, 2025 and issued its decision on Oct 31, 2025, 267 days later.

← All decisions in October 2025