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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 / July 2026 / K261009

510(k) cleared

MobileLink Acetabular Cup System 40mm ID Inserts (various)

Waldemar Link GmbH & Co. KG · Jul 6, 2026 · K261009

FDA cleared the MobileLink Acetabular Cup System 40mm ID Inserts (various) from Waldemar Link GmbH & Co. KG on Jul 6, 2026 under K261009, 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 Mar 26, 2026. The decision came 102 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Waldemar Link GmbH & Co. KG has one other decision in the tracker over the last 12 months: K250375 (Allure Hip Stem and Intramedullary Plugs).

Questions & Answers

What did FDA clear under K261009?

K261009 is the FDA 510(k) for MobileLink Acetabular Cup System 40mm ID Inserts (various), submitted by Waldemar Link GmbH & Co. KG. FDA's decision date was Jul 6, 2026, under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented).

Who makes the MobileLink Acetabular Cup System 40mm ID Inserts (various)?

Waldemar Link GmbH & Co. KG, based in Hamburg, is the applicant of record for K261009.

How long did the K261009 review take?

FDA received the submission on Mar 26, 2026 and issued its decision on Jul 6, 2026, 102 days later.

← All decisions in July 2026

Sources