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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 / April 2026 / K252451

510(k) cleared

EPORE® XO cup system

Implantcast GmbH · Apr 24, 2026 · K252451

FDA cleared the EPORE® XO cup system from Implantcast GmbH on Apr 24, 2026 under K252451, a traditional 510(k). The device falls under product code OQI, Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, 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 Aug 4, 2025. The decision came 263 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Implantcast GmbH has 2 other decisions in the tracker over the last 12 months: K260037 (implantcast Packaging System Update), K252401 (implaFit® short stems).

Questions & Answers

What did FDA clear under K252451?

K252451 is the FDA 510(k) for EPORE® XO cup system, submitted by Implantcast GmbH. FDA's decision date was Apr 24, 2026, under product code OQI (Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented).

Who makes the EPORE® XO cup system?

Implantcast GmbH, based in Buxtehude, is the applicant of record for K252451.

How long did the K252451 review take?

FDA received the submission on Aug 4, 2025 and issued its decision on Apr 24, 2026, 263 days later.

← All decisions in April 2026

Sources