510(k) K262253

Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) by Orthalign, Inc. — Product Code ONN

K262253 is an FDA 510(k) premarket notification submitted by Orthalign, Inc. for the device "Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)". The FDA issued a decision of Substantially Equivalent on July 31, 2026. The device falls under product code ONN (Intraoperative Orthopedic Joint Assessment Aid), a Class II device regulated under 21 CFR 882.4560. Orthalign, Inc. has at least 10 other 510(k) clearances on record.