Cleared Traditional

K183381 - Navigation Enabled Instruments

K183381 is the FDA 510(k) clearance for Navigation Enabled Instruments by Stryker. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K183381 · Stryker · Orthopedic device
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May 2019
Decision
162d
Days
Class 2
Risk

K183381 is an FDA 510(k) clearance for the Navigation Enabled Instruments. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Stryker (Allendale, US). The FDA issued a Cleared decision on May 17, 2019 after a review of 162 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.

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Submission Details

510(k) Number K183381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2018
Decision Date May 17, 2019
Days to Decision 162 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
40d slower than avg
Panel avg: 122d · This submission: 162d
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 365
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K183381.
Spine & Trauma Navigation
K191285 · Brainlab AG · Jun 2019
SPINEART Navigation Instrument System
K183630 · Spineart SA · Jun 2019
Stealth-Midas MR8 System
K183644 · Medtronic Powered Surgical Solutions · May 2019
ExcelsiusGPS
K190653 · Globus Medical, Inc. · Apr 2019
ROSA ONE Spine application
K182848 · Medtech S.A · Mar 2019
Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker
K183196 · Stryker Corporation · Feb 2019