Cleared Traditional

K163581 - Navigated ELEVATE Inserter

K163581 is the FDA 510(k) clearance for Navigated ELEVATE Inserter by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K163581 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Apr 2017
Decision
115d
Days
Class 2
Risk

K163581 is an FDA 510(k) clearance for the Navigated ELEVATE Inserter, Navigated Disc Prep 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 Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on April 14, 2017 after a review of 115 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.

View all Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K163581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2016
Decision Date April 14, 2017
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
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 K163581.
SURESHOT Distal Targeting System V4.0 Trauma Interface
K170977 · Smith & Nephew, Inc. · May 2017
Smith & Nephew SURESHOT Distal Targeting System V4.0
K170280 · Smith & Nephew, Inc. · Apr 2017
Mako Total Hip Application
K170593 · Mako Surgical Corp. · Apr 2017
Navigated Instrument System
K162921 · Orthofix, Inc. · Mar 2017
Stryker OrthoMap Versatile Hip System
K162937 · Stryker Corporation · Feb 2017
Alphatec Navigation Instruments
K153603 · Alphatec Spine, Inc. · Apr 2016