Lantern Knee Navigation Unit (406000-03); Lantern Hip Navigation Unit (502000-03)— 510(k) K262253

Name: FDA 510(k) clearance K262253
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Substantially Equivalent

Orthalign, Inc.

FDA 510(k) clearance K262253 for Lantern Knee Navigation Unit (406000-03); Lantern Hip Navigation Unit (502000-03), Substantially Equivalent on 2026-07-31. Applicant: Orthalign, Inc.. Device class: 2.

Clearance details

Device name as filed: Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)
Applicant: Orthalign, Inc.
Product code: Code ONN
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2026-07-02
Decision date: 2026-07-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ONN

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K253507 — Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee2026-06-02
K252524 — Quadsense (Quadsense and Quadsense Pro)2025-09-09
K241298 — QUADSENSE2024-10-04
K242616 — Lantern® Hip2024-10-03
K220830 — TrueBalance Surgical System2022-09-15

More clearances from Orthalign, Inc.

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K200892 — Harvey(R) Surgical Assistant2020-06-18
K200642 — OrthAlign Plus System2020-04-10
K172462 — OrthAlign Plus System2017-11-22
K171780 — OrthAlign Plus System2017-07-11
K163379 — KneeAlign 2 System2017-03-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.