Cleared Special

K072899 - ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K072899 · Aesculap Implant Systems, Inc. · Neurology device
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Feb 2008
Decision
118d
Days
Class 2
Risk

K072899 is an FDA 510(k) clearance for the ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Aesculap Implant Systems, Inc. (Center Valley, US). The FDA issued a Cleared decision on February 6, 2008 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aesculap Implant Systems, Inc. devices

Submission Details

510(k) Number K072899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2007
Decision Date February 06, 2008
Days to Decision 118 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 148d · This submission: 118d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 422
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