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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 / April 2026 / K253805

510(k) cleared

Knee+

Pixee Medical S.A.S. · Apr 24, 2026 · K253805

FDA cleared the Knee+ from Pixee Medical S.A.S. on Apr 24, 2026 under K253805, a traditional 510(k). The device falls under product code SBF, Orthopedic Augmented Reality, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Nov 28, 2025. The decision came 147 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 Pixee Medical S.A.S. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253805?

K253805 is the FDA 510(k) for Knee+, submitted by Pixee Medical S.A.S.. FDA's decision date was Apr 24, 2026, under product code SBF (Orthopedic Augmented Reality).

Who makes the Knee+?

Pixee Medical S.A.S., based in Besançon, is the applicant of record for K253805.

How long did the K253805 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Apr 24, 2026, 147 days later.

← All decisions in April 2026