Cleared Traditional

OrthAlign Plus System (K172462) - FDA 510(k) Clearance

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

K172462 · Orthalign, Inc. · Orthopedic device
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Nov 2017
Decision
100d
Days
Class 2
Risk

K172462 is an FDA 510(k) clearance for the OrthAlign Plus System. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Orthalign, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on November 22, 2017 after a review of 100 days - within the typical 510(k) review window.

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 K172462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2017
Decision Date November 22, 2017
Days to Decision 100 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 122d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
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 - OLO Orthopedic Stereotaxic Instrument

All 345
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K172462.
K2M Navigation Instruments
K171556 · K2m · Jan 2018
Spineology Navigation Instruments
K172518 · Spineology, Inc. · Jan 2018
NuVasive Navigation Instruments
K172623 · Nu Vasive, Incorporated · Dec 2017
Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap
K172034 · Stryker Corporation · Oct 2017
VIPER PRIME navigated inserter
K170937 · Medos International SARL · Sep 2017
EXCELSIUS GPS
K171651 · Globus Medical, Inc. · Aug 2017