Cleared Traditional

K253507 - Packaged Assembly, Reusable Navigation Unit

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

K253507 is an FDA 510(k) clearance for Packaged Assembly, manufactured by Orthalign, Inc.. The device is a Class 2 Orthopedic device with product code ONN cleared through the Traditional 510(k) pathway after a 211-day FDA review.

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

FDA 510(k) Submission Details - K253507

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.

ONN Device Classification - Class 2, Special Controls

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 17
Devices cleared under the same product code (ONN) and FDA review panel - the closest regulatory comparables to K253507.
Lantern Knee Navigation Unit (406000-03)
K262253 · Orthalign, Inc. · Jul 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