Cleared Special

PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS (K031495) - FDA 510(k) Clearance

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

K031495 · DePuy Orthopaedics, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2003
Decision
29d
Days
Class 2
Risk

K031495 is an FDA 510(k) clearance for the PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 11, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory 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 K031495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2003
Decision Date June 11, 2003
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 Orthopedic devices follow this clearance model.

Regulatory Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 324
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K031495.
MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA
K031693 · Biomet, Inc. · Aug 2003
ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923
K031572 · Zimmer, Inc. · Jun 2003
HA PMI FLANGED ACETABULAR COMPONENT
K030861 · Biomet, Inc. · Jun 2003
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES
K030733 · Zimmer, Inc. · May 2003
MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K030979 · DePuy Orthopaedics, Inc. · Apr 2003
X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
K030501 · Biomet, Inc. · Mar 2003