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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 / June 2026 / K253507

510(k) cleared

Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee

Orthalign, Inc. · Jun 2, 2026 · K253507

FDA cleared the Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee from Orthalign, Inc. on Jun 2, 2026 under K253507, a traditional 510(k). The device falls under product code ONN, Intraoperative Orthopedic Joint Assessment Aid, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Nov 3, 2025. The decision came 211 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Orthalign, Inc. has one other decision in the tracker over the last 12 months: K262253 (Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)).

Questions & Answers

What did FDA clear under K253507?

K253507 is the FDA 510(k) for Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee, submitted by Orthalign, Inc.. FDA's decision date was Jun 2, 2026, under product code ONN (Intraoperative Orthopedic Joint Assessment Aid).

Who makes the Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee?

Orthalign, Inc., based in Irvine, CA, is the applicant of record for K253507.

How long did the K253507 review take?

FDA received the submission on Nov 3, 2025 and issued its decision on Jun 2, 2026, 211 days later.

← All decisions in June 2026

Sources