Cleared Traditional

SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM (K031196) - FDA 510(k) Clearance

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

K031196 · Praxim · Neurology device
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Jun 2005
Decision
783d
Days
Class 2
Risk

K031196 is an FDA 510(k) clearance for the SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Praxim (North Attleboro, US). The FDA issued a Cleared decision on June 7, 2005 after a review of 783 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Praxim devices

Submission Details

510(k) Number K031196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2003
Decision Date June 07, 2005
Days to Decision 783 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
635d slower than avg
Panel avg: 148d · This submission: 783d
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 K031196.
BRIGIT SURGICAL DEVICE
K060556 · Zimmer, Inc. · Jul 2006
ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION
K052425 · Zimmer, Inc. · Dec 2005
DEPUY CAS HIP INSTRUMENTATION
K052178 · DePuy Orthopaedics, Inc. · Oct 2005
AESCULAP ORTHOPILOT 2 THA V 2.0
K050752 · Aesculap, Inc. · Apr 2005
DEPUY CAS KNEE INSTRUMENTATION
K043223 · DePuy Orthopaedics, Inc. · Mar 2005
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K033341 · Smith & Nephew, Inc. · Sep 2004