Cleared Traditional

INTAI Surgery Navigation System (K180523) - FDA 510(k) Clearance

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

K180523 · Intai Technology Corporation · Orthopedic device
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Sep 2019
Decision
570d
Days
Class 2
Risk

K180523 is an FDA 510(k) clearance for the INTAI Surgery Navigation 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 Intai Technology Corporation (Taichung, TW). The FDA issued a Cleared decision on September 20, 2019 after a review of 570 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Intai Technology Corporation devices

Submission Details

510(k) Number K180523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2018
Decision Date September 20, 2019
Days to Decision 570 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
448d slower than avg
Panel avg: 122d · This submission: 570d
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 344
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K180523.
Intellijoint® Navigation System
K191507 · Intellijoint Surgical, Inc. · Oct 2019
Precision Spine Navigation Instrumentation
K181606 · Precision Spine, Inc. · Sep 2019
Mako Total Hip Application, Mako Total Knee Application
K191998 · Mako Surgical Corp. · Sep 2019
Spine & Trauma Navigation
K183605 · Brainlab AG · Aug 2019
Navigated T2 STRATOSPHERE Inserters and Navigated Templates
K191039 · Medtronic Sofamor Danek USA, Inc. · Aug 2019
Navigated Pedicle Access Kit
K191012 · Izi Medical Products, LLC · Aug 2019