Cleared Traditional

ORTHALIGN PLUS SYSTEM (K140331) - FDA 510(k) Clearance

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

K140331 · Orthalign, Inc. · Orthopedic device
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Jun 2014
Decision
120d
Days
Class 2
Risk

K140331 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 June 10, 2014 after a review of 120 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 K140331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2014
Decision Date June 10, 2014
Days to Decision 120 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
2d faster than avg
Panel avg: 122d · This submission: 120d
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 K140331.
Navigation Instruments
K153203 · Globus Medical, Inc. · Feb 2016
Navigated Disc Prep Instruments and CAPSTONE Trials
K150231 · Medtronic Sofamor Danek USA, Inc. · Jun 2015
Navigated Vertex Select Instruments
K143628 · Medtronic Sofamor Danek USA, Inc. · Feb 2015
NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
K140454 · Medtronic Sofamor Danek USA, Inc. · May 2014
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
K130748 · Smith & Nephew, Inc. · Aug 2013
NAVIGATION SOFTWARE HIP-UNIVERSAL
K122011 · Brainlab AG · Nov 2012