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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 / July 2026 / K262253

510(k) cleared

Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)

Orthalign, Inc. · Jul 31, 2026 · K262253

FDA cleared the Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) from Orthalign, Inc. on Jul 31, 2026 under K262253, a special 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 Jul 2, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Orthalign, Inc. has one other decision in the tracker over the last 12 months: K253507 (Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee).

Questions & Answers

What did FDA clear under K262253?

K262253 is the FDA 510(k) for Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03), submitted by Orthalign, Inc.. FDA's decision date was Jul 31, 2026, under product code ONN (Intraoperative Orthopedic Joint Assessment Aid).

Who makes the Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)?

Orthalign, Inc., based in Irvine, CA, is the applicant of record for K262253.

How long did the K262253 review take?

FDA received the submission on Jul 2, 2026 and issued its decision on Jul 31, 2026, 29 days later.

← All decisions in July 2026

Sources