Cleared Traditional

K072267 - TOTAL HIP SURGETICS NAVIGATION SYSTEM

K072267 is an FDA 510(k) clearance for TOTAL HIP SURGETICS NAVIGATION SYSTEM, manufactured by Praxim S.A. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K072267 · Praxim S.A · Neurology device
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Dec 2007
Decision
117d
Days
Class 2
Risk

K072267 is an FDA 510(k) clearance for the TOTAL HIP 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 December 10, 2007 after a review of 117 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 S.A devices

FDA 510(k) Submission Details - K072267

510(k) Number K072267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2007
Decision Date December 10, 2007
Days to Decision 117 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
31d faster than avg
Panel avg: 148d · This submission: 117d
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 292
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K072267.
ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0
K072899 · Aesculap Implant Systems, Inc. · Feb 2008
MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)
K072806 · Mako Surgical Corp. · Jan 2008
STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE
K072271 · Stryker Corp. · Dec 2007
VECTOR VISION HIP
K072716 · Brainlab AG · Oct 2007
VECTORVISION HIP AND HIP SR
K072573 · Brainlab AG · Oct 2007
BRAINSUITE NET
K070556 · Brainlab AG · Sep 2007