Cleared Special

PINNACLE REVISION SYSTEM (K033338) - FDA 510(k) Clearance

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

K033338 · DePuy Orthopaedics, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 2004
Decision
83d
Days
Class 2
Risk

K033338 is an FDA 510(k) clearance for the PINNACLE REVISION SYSTEM. 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 January 8, 2004 after a review of 83 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 K033338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2003
Decision Date January 08, 2004
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 K033338.
TRIFLANGE II ACETABULAR CUP SYSTEM
K040383 · DePuy Orthopaedics, Inc. · May 2004
DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS
K033273 · DePuy Orthopaedics, Inc. · May 2004
SPECTRUM MODULAR SYSTEM
K033893 · DePuy Orthopaedics, Inc. · Mar 2004
EXACTECH 12/14 ALUMINA FEMORAL HEAD
K032964 · Exactech, Inc. · Nov 2003
VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
K033034 · Zimmer, Inc. · Nov 2003
ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES
K032726 · Zimmer, Inc. · Oct 2003