Cleared Special

K262253 - Lantern Knee Navigation Unit (406000-03)

Also marketed or referenced as:
Lantern Hip Navigation Unit (502000-03)

K262253 is the FDA 510(k) clearance for Lantern Knee Navigation Unit (406000-03) by Orthalign, Inc.. It is a Class 2 Orthopedic device (product code ONN) cleared through the Special 510(k) pathway after a 29-day FDA review.

K262253 · Orthalign, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
29d
Days
Class 2
Risk

K262253 is an FDA 510(k) clearance for the Lantern Knee Navigation Unit (406000-03). Classified as Intraoperative Orthopedic Joint Assessment Aid (product code ONN), Class II - Special Controls.

Submitted by Orthalign, Inc. (Irvine, US). The FDA issued a Cleared decision on July 31, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Orthalign, Inc. devices

Submission Details

510(k) Number K262253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2026
Decision Date July 31, 2026
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ONN Intraoperative Orthopedic Joint Assessment Aid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Measurement And Interpretation Of Orthopedic Joint Information.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - ONN Intraoperative Orthopedic Joint Assessment Aid

All 9
Devices cleared under the same product code (ONN) and FDA review panel - the closest regulatory comparables to K262253.
Packaged Assembly, Reusable Navigation Unit
K253507 · Orthalign, Inc. · Jun 2026
Quadsense (Quadsense and Quadsense Pro)
K252524 · Eventum Orthopaedics, Ltd. · Sep 2025
QUADSENSE
K241298 · Eventum Orthopaedics, Ltd. · Oct 2024
Lantern® Hip
K242616 · Orthalign, Inc. · Oct 2024
TrueBalance™ Surgical System
K220830 · These Three Medical, LLC · Sep 2022
VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder
K200587 · Orthosensor, Inc. · Aug 2020