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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 / September 2025 / K250450

510(k) cleared

Coated hip implants

Medacta International S.A. · Sep 19, 2025 · K250450

FDA cleared the Coated hip implants from Medacta International S.A. on Sep 19, 2025 under K250450, a traditional 510(k). The device falls under product code LZO, Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, regulated at 21 CFR 888.3353 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 18, 2025. The decision came 213 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 K250450?

K250450 is the FDA 510(k) for Coated hip implants, submitted by Medacta International S.A.. FDA's decision date was Sep 19, 2025, under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented).

Who makes the Coated hip implants?

Medacta International S.A., based in Castel San Pietro, is the applicant of record for K250450.

How long did the K250450 review take?

FDA received the submission on Feb 18, 2025 and issued its decision on Sep 19, 2025, 213 days later.

← All decisions in September 2025