Cleared Traditional

K143597 - Navigated XIA 4.5 Polyaxial Screwdriver

K143597 is an FDA 510(k) clearance for Navigated XIA 4.5 Polyaxial Screwdriver, manufactured by Stryker Corporate. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K143597 · Stryker Corporate · Orthopedic device
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Sep 2015
Decision
260d
Days
Class 2
Risk

K143597 is an FDA 510(k) clearance for the Navigated XIA 4.5 Polyaxial Screwdriver. 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 Corporate (Freiburg, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on September 4, 2015 after a review of 260 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.

View all Stryker Corporate devices

FDA 510(k) Submission Details - K143597

510(k) Number K143597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2014
Decision Date September 04, 2015
Days to Decision 260 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 122d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLO Device Classification - Class 2, Special Controls

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 366
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K143597.
Stryker OrthoMap Versatile Hip System
K162937 · Stryker Corporation · Feb 2017
Alphatec Navigation Instruments
K153603 · Alphatec Spine, Inc. · Apr 2016
Navigation Instruments
K153203 · Globus Medical, Inc. · Feb 2016
Total Knee Application (TKA)
K143752 · Mako Surgical Corp. · Aug 2015
Navigated Disc Prep Instruments and CAPSTONE Trials
K150231 · Medtronic Sofamor Danek USA, Inc. · Jun 2015
Navigated Vertex Select Instruments
K143628 · Medtronic Sofamor Danek USA, Inc. · Feb 2015