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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 / K252847

510(k) cleared

NextAR Hip Platform

Medacta International S.A. · Jan 9, 2026 · K252847

FDA cleared the NextAR Hip Platform from Medacta International S.A. on Jan 9, 2026 under K252847, a traditional 510(k). The device falls under product code SBF, Orthopedic Augmented Reality, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 8, 2025. The decision came 123 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 K252847?

K252847 is the FDA 510(k) for NextAR Hip Platform, submitted by Medacta International S.A.. FDA's decision date was Jan 9, 2026, under product code SBF (Orthopedic Augmented Reality).

Who makes the NextAR Hip Platform?

Medacta International S.A., based in Castel San Pietro, is the applicant of record for K252847.

How long did the K252847 review take?

FDA received the submission on Sep 8, 2025 and issued its decision on Jan 9, 2026, 123 days later.

← All decisions in January 2026