Cleared Traditional

Packaged Assembly, Reusable Navigation Unit (K253507) - FDA 510(k) Clearance

Also marketed or referenced as:
Lantern ASC, Smart Pack kit, Knee

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253507 · Orthalign, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
211d
Days
Class 2
Risk

K253507 is an FDA 510(k) clearance for the Packaged Assembly, Reusable Navigation Unit. 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 June 2, 2026 after a review of 211 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Orthalign, Inc. devices

Submission Details

510(k) Number K253507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2025
Decision Date June 02, 2026
Days to Decision 211 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 122d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 16
Devices cleared under the same product code (ONN) and FDA review panel - the closest regulatory comparables to K253507.
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
VERASENSE for Stryker Triathlon
K200665 · Orthosensor, Inc. · Apr 2020