WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / November 2025 / K250375

510(k) cleared

Allure Hip Stem and Intramedullary Plugs

Waldemar Link GmbH & Co. KG · Nov 5, 2025 · K250375

FDA cleared the Allure Hip Stem and Intramedullary Plugs from Waldemar Link GmbH & Co. KG on Nov 5, 2025 under K250375, a traditional 510(k). The device falls under product code MEH, Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, regulated at 21 CFR 888.3353 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 10, 2025. The decision came 268 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: K261009 (MobileLink Acetabular Cup System 40mm ID Inserts (various)).

Questions & Answers

What did FDA clear under K250375?

K250375 is the FDA 510(k) for Allure Hip Stem and Intramedullary Plugs, submitted by Waldemar Link GmbH & Co. KG. FDA's decision date was Nov 5, 2025, under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate).

Who makes the Allure Hip Stem and Intramedullary Plugs?

Waldemar Link GmbH & Co. KG, based in Hamburg, is the applicant of record for K250375.

How long did the K250375 review take?

FDA received the submission on Feb 10, 2025 and issued its decision on Nov 5, 2025, 268 days later.

← All decisions in November 2025

Sources