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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 / January 2026 / K251043

510(k) cleared

Mpact 3D Metal Implants Extension DMLS Technology

Medacta International S.A. · Jan 28, 2026 · K251043

FDA cleared the Mpact 3D Metal Implants Extension DMLS Technology from Medacta International S.A. on Jan 28, 2026 under K251043, a traditional 510(k). The device falls under product code LPH, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, regulated at 21 CFR 888.3358 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 3, 2025. The decision came 300 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 K251043?

K251043 is the FDA 510(k) for Mpact 3D Metal Implants Extension DMLS Technology, submitted by Medacta International S.A.. FDA's decision date was Jan 28, 2026, under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented).

Who makes the Mpact 3D Metal Implants Extension DMLS Technology?

Medacta International S.A., based in Castel San Pietro, is the applicant of record for K251043.

How long did the K251043 review take?

FDA received the submission on Apr 3, 2025 and issued its decision on Jan 28, 2026, 300 days later.

← All decisions in January 2026