Cleared Traditional

K172034 - Stryker Spine Navigation System with Sp...

K172034 is the FDA 510(k) clearance for Stryker Spine Navigation System with Sp... by Stryker Corporation. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K172034 · Stryker Corporation · Orthopedic device
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Oct 2017
Decision
105d
Days
Class 2
Risk

K172034 is an FDA 510(k) clearance for the Stryker Spine Navigation System with SpineMap 3D software application, OrthoL.... 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 October 18, 2017 after a review of 105 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.

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Submission Details

510(k) Number K172034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2017
Decision Date October 18, 2017
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
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 K172034.
NuVasive Navigation Instruments
K172623 · Nu Vasive, Incorporated · Dec 2017
Mako Partial Knee Application
K172301 · Mako Surgical Corp. · Nov 2017
iFuse Implant System- iFuse Navigation
K172268 · SI-BONE, Inc. · Oct 2017
Mako Total Knee Application
K172219 · Mako Surgical Corp. · Sep 2017
VIPER PRIME navigated inserter
K170937 · Medos International SARL · Sep 2017
EXCELSIUS GPS
K171651 · Globus Medical, Inc. · Aug 2017