Cleared Traditional

K071334 - DEPUY CAS HEMI ASR HIP INSTRUMENTS

K071334 is an FDA 510(k) clearance for DEPUY CAS HEMI ASR HIP INSTRUMENTS, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 52-day FDA review.

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

FDA 510(k) Submission Details - K071334

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
97d faster than avg
Panel avg: 149d · This submission: 52d
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 385
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K071334.
SPINEASSIST SYSTEM
K063607 · Mazor Surgical Technologies , Ltd. · Aug 2007
PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM
K070731 · Plus Orthopedics AG · Jul 2007
NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003
K071714 · Orthosoft, Inc. · Jul 2007
DEPUY CI HIP INSTRUMENTATION
K071135 · DePuy Orthopaedics, Inc. · May 2007
VV FLUORO 3D
K070106 · Brainlab AG · Apr 2007
ARGOS
K061479 · 3D Line Medical Systems S.R.L. · Apr 2007