Cleared Special

DEPUY CI HIP INSTRUMENTATION (K071135) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K071135 · DePuy Orthopaedics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
30d
Days
Class 2
Risk

K071135 is an FDA 510(k) clearance for the DEPUY CI HIP INSTRUMENTATION. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 23, 2007 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K071135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2007
Decision Date May 23, 2007
Days to Decision 30 days
Submission Type Special
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
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 159
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K071135.
VECTORVISION HIP AND HIP SR
K072573 · Brainlab AG · Oct 2007
BRAINSUITE NET
K070556 · Brainlab AG · Sep 2007
DEPUY CAS HEMI ASR HIP INSTRUMENTS
K071334 · DePuy Orthopaedics, Inc. · Jul 2007
VV FLUORO 3D
K070106 · Brainlab AG · Apr 2007
MODIFICATION TO VECTORVISION TRAUMA
K062358 · Brainlab AG · Jan 2007
VECTORVISION HIP SR
K063028 · Brainlab AG · Dec 2006