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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 / K254253

510(k) cleared

LOQTEQ® VA Proximal Humerus Plate 3.5

Aap Implantate AG · Mar 24, 2026 · K254253

FDA cleared the LOQTEQ® VA Proximal Humerus Plate 3.5 from Aap Implantate AG on Mar 24, 2026 under K254253, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 29, 2025. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Aap Implantate AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254253?

K254253 is the FDA 510(k) for LOQTEQ® VA Proximal Humerus Plate 3.5, submitted by Aap Implantate AG. FDA's decision date was Mar 24, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the LOQTEQ® VA Proximal Humerus Plate 3.5?

Aap Implantate AG, based in Berlin, is the applicant of record for K254253.

How long did the K254253 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Mar 24, 2026, 85 days later.

← All decisions in March 2026