Cleared Traditional

K153396 - Aesculap OrthoPilot Next Generation

K153396 is the FDA 510(k) clearance for Aesculap OrthoPilot Next Generation by Aesculap Implant Systems, LLC. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K153396 · Aesculap Implant Systems, LLC · Orthopedic device
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May 2016
Decision
174d
Days
Class 2
Risk

K153396 is an FDA 510(k) clearance for the Aesculap OrthoPilot Next Generation. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Aesculap Implant Systems, LLC (Center Valley, US). The FDA issued a Cleared decision on May 16, 2016 after a review of 174 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 Aesculap Implant Systems, LLC devices

Submission Details

510(k) Number K153396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2015
Decision Date May 16, 2016
Days to Decision 174 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
52d slower than avg
Panel avg: 122d · This submission: 174d
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 355
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K153396.
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
K163581 · Medtronic Sofamor Danek USA, Inc. · 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
Navigation Instruments
K153203 · Globus Medical, Inc. · Feb 2016
Navigated Disc Prep Instruments and CAPSTONE Trials
K150231 · Medtronic Sofamor Danek USA, Inc. · Jun 2015