Cleared Traditional

K053542 - SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM

K053542 is an FDA 510(k) clearance for SURGETICS ORTHO OSTEOLOGICS NAVIGATION ..., 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 111-day FDA review.

K053542 · Praxim S.A · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
111d
Days
Class 2
Risk

K053542 is an FDA 510(k) clearance for the SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Praxim S.A (North Attleboro, US). The FDA issued a Cleared decision on April 10, 2006 after a review of 111 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.

FDA 510(k) Submission Details - K053542

510(k) Number K053542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2005
Decision Date April 10, 2006
Days to Decision 111 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 149d · This submission: 111d
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 426
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K053542.
BRAINPRO, BRAINPRO ACCESS
K060808 · PAJUNK GmbH Medizintechnologie · Jul 2006
VECTORVISION SPINE
K053159 · Brainlab AG · Jun 2006
NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002
K060336 · Orthosoft, Inc. · Apr 2006
TOTAL KNEE SURGETICS NAVIGATION SYSTEM
K060282 · Praxim S.A · Apr 2006
IPLAN FLOW
K053164 · Brainlab AG · Mar 2006
BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS
K060121 · Biomet Manufacturing Corp · Mar 2006
K053542 · SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM
Download PDF FDA Summary Praxim S.A