Cleared Traditional

TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES (K081232) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081232 · Praxim · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 105
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K081232.
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
K100314 · Medacta International S.A. · Mar 2010
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
K083565 · Smith & Nephew, Inc. · Feb 2009
PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
K082267 · Smith & Nephew, Inc. · Oct 2008
PIGALILEO 4TH GENERATION SYSTEM
K080875 · Smith & Nephew, Inc. · Jul 2008
DEPUY CAS HEMI ASR HIP INSTRUMENTS
K071334 · DePuy Orthopaedics, Inc. · Jul 2007
DEPUY CI HIP INSTRUMENTATION
K071135 · DePuy Orthopaedics, Inc. · May 2007