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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 / May 2026 / K260268

510(k) cleared

OrthoEasy Pal; OrthoEasy Pal Long Neck

Bernhard Förster GmbH (Bernhard Foerster Ltd.) · May 19, 2026 · K260268

FDA cleared the OrthoEasy Pal; OrthoEasy Pal Long Neck from Bernhard Förster GmbH (Bernhard Foerster Ltd.) on May 19, 2026 under K260268, a traditional 510(k). The device falls under product code OAT, Implant, Endosseous, Orthodontic, regulated at 21 CFR 872.3640 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jan 28, 2026. The decision came 111 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Bernhard Förster GmbH (Bernhard Foerster Ltd.) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260268?

K260268 is the FDA 510(k) for OrthoEasy Pal; OrthoEasy Pal Long Neck, submitted by Bernhard Förster GmbH (Bernhard Foerster Ltd.). FDA's decision date was May 19, 2026, under product code OAT (Implant, Endosseous, Orthodontic).

Who makes the OrthoEasy Pal; OrthoEasy Pal Long Neck?

Bernhard Förster GmbH (Bernhard Foerster Ltd.), based in Pforzheim, is the applicant of record for K260268.

How long did the K260268 review take?

FDA received the submission on Jan 28, 2026 and issued its decision on May 19, 2026, 111 days later.

← All decisions in May 2026