Cleared Traditional

K013569 - ORTHOPILOT 2

K013569 is an FDA 510(k) clearance for ORTHOPILOT 2, manufactured by Aesculap, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K013569 · Aesculap, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
157d
Days
Class 2
Risk

K013569 is an FDA 510(k) clearance for the ORTHOPILOT 2. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on April 4, 2002 after a review of 157 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Aesculap, Inc. devices

FDA 510(k) Submission Details - K013569

510(k) Number K013569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2001
Decision Date April 04, 2002
Days to Decision 157 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 148d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 333
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K013569.
NAVIPRO
K020764 · Kinamed, Inc. · Jun 2002
GALILEO CAS/NAV TKR SYSTEM
K020298 · Plus Orthopedics · May 2002
MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM
K013428 · Ohio Medical Instrument Co., Inc. · Apr 2002
VECTORVISION TRAUMA
K012448 · Brainlab AG · Mar 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS
K012938 · Smith & Nephew, Inc. · Feb 2002
MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE
K013861 · Elekta Instrument AB · Dec 2001