Cleared Special

K062146 - UNI KNEE SURGETICS NAVIGATION SYSTEM

K062146 is an FDA 510(k) clearance for UNI KNEE SURGETICS NAVIGATION SYSTEM, manufactured by Praxim S.A. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 25-day FDA review.

K062146 · Praxim S.A · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
25d
Days
Class 2
Risk

K062146 is an FDA 510(k) clearance for the UNI KNEE SURGETICS NAVIGATION SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Praxim S.A (La Tronche, FR). The FDA issued a Cleared decision on August 21, 2006 after a review of 25 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Praxim S.A devices

FDA 510(k) Submission Details - K062146

510(k) Number K062146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2006
Decision Date August 21, 2006
Days to Decision 25 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
123d faster than avg
Panel avg: 148d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 292
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K062146.
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