Cleared Traditional

K183196 - Stryker Navigation System with SpineMap...

K183196 is the FDA 510(k) clearance for Stryker Navigation System with SpineMap... by Stryker Corporation. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K183196 · Stryker Corporation · Orthopedic device
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Feb 2019
Decision
87d
Days
Class 2
Risk

K183196 is an FDA 510(k) clearance for the Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy .... 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 Corporation (Freiburg, DE). The FDA issued a Cleared decision on February 14, 2019 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Corporation devices

Submission Details

510(k) Number K183196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2018
Decision Date February 14, 2019
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
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 K183196.
Navigation Enabled Instruments
K183381 · Stryker · May 2019
ExcelsiusGPS
K190653 · Globus Medical, Inc. · Apr 2019
ROSA ONE Spine application
K182848 · Medtech S.A · Mar 2019
ROSA Knee System
K182964 · Orthosoft Inc. (d/b/a) Zimmer CAS · Jan 2019
Choice Spine Navigation System
K182721 · Choicespine, LP · Jan 2019
BridalVeil Navigated Instruments
K182982 · Astura Medical · Jan 2019