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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 / March 2026 / K260037

510(k) cleared

implantcast Packaging System Update

Implantcast GmbH · Mar 30, 2026 · K260037

FDA cleared the implantcast Packaging System Update from Implantcast GmbH on Mar 30, 2026 under K260037, 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 Jan 6, 2026. The decision came 83 days later, inside the 90 FDA-day goal for a 510(k).

Implantcast GmbH has 2 other decisions in the tracker over the last 12 months: K252451 (EPORE® XO cup system), K252401 (implaFit® short stems).

Questions & Answers

What did FDA clear under K260037?

K260037 is the FDA 510(k) for implantcast Packaging System Update, submitted by Implantcast GmbH. FDA's decision date was Mar 30, 2026, under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented).

Who makes the implantcast Packaging System Update?

Implantcast GmbH, based in Buxtehude, is the applicant of record for K260037.

How long did the K260037 review take?

FDA received the submission on Jan 6, 2026 and issued its decision on Mar 30, 2026, 83 days later.

← All decisions in March 2026

Sources