Cleared Traditional

K081232 - TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES

K081232 is an FDA 510(k) clearance for TOTAL KNEE SURGETICS NAVIGATION SYSTEM ..., manufactured by Praxim. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K081232 · Praxim · Neurology device
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Aug 2008
Decision
97d
Days
Class 2
Risk

K081232 is an FDA 510(k) clearance for the TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Praxim (La Tronche, FR). The FDA issued a Cleared decision on August 6, 2008 after a review of 97 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. 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 Praxim devices

FDA 510(k) Submission Details - K081232

510(k) Number K081232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2008
Decision Date August 06, 2008
Days to Decision 97 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 148d · This submission: 97d
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 287
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K081232.
MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0
K081867 · Mako Surgical Corp. · Nov 2008
PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
K082267 · Smith & Nephew, Inc. · Oct 2008
BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED
K073615 · Brainlab AG · Sep 2008
PIGALILEO 4TH GENERATION SYSTEM
K080875 · Smith & Nephew, Inc. · Jul 2008
STRYKER POWER TOOL NAVIGATOR ATTACHMENT
K080450 · Stryker Corp. · Jul 2008
UNI-KNEE 2.0
K080678 · Brainlab AG · Jun 2008