Cleared Traditional

K103400 - FLUOROMAP SOFTWARE

K103400 is the FDA 510(k) clearance for FLUOROMAP SOFTWARE by Stryker Corporation. It is a Class 2 Radiology device (product code OLO) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K103400 · Stryker Corporation · Radiology device
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Mar 2011
Decision
108d
Days
Class 2
Risk

K103400 is an FDA 510(k) clearance for the FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP. 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, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on March 7, 2011 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 882.4560 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Corporation devices

Submission Details

510(k) Number K103400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2010
Decision Date March 07, 2011
Days to Decision 108 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 107d · This submission: 108d
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 Radiology devices follow this clearance model.

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 365
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