Cleared Traditional

DEPUY CAS HEMI ASR HIP INSTRUMENTS (K071334) - FDA 510(k) Clearance

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

K071334 · DePuy Orthopaedics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
52d
Days
Class 2
Risk

K071334 is an FDA 510(k) clearance for the DEPUY CAS HEMI ASR HIP INSTRUMENTS. 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 July 2, 2007 after a review of 52 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K071334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2007
Decision Date July 02, 2007
Days to Decision 52 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
96d faster than avg
Panel avg: 148d · This submission: 52d
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 159
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K071334.
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
DEPUY CI HIP INSTRUMENTATION
K071135 · DePuy Orthopaedics, Inc. · May 2007
VV FLUORO 3D
K070106 · Brainlab AG · Apr 2007
MODIFICATION TO VECTORVISION TRAUMA
K062358 · Brainlab AG · Jan 2007