Cleared Traditional

SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT (K033382) - FDA 510(k) Clearance

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

K033382 · DePuy Orthopaedics, Inc. · Orthopedic device
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Feb 2004
Decision
105d
Days
Class 2
Risk

K033382 is an FDA 510(k) clearance for the SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 5, 2004 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K033382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2003
Decision Date February 05, 2004
Days to Decision 105 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LOD Bone Cement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - LOD Bone Cement

All 48
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K033382.
SIMPLEX X
K032945 · Stryker Corp. · May 2004
CEMEX GENTA BONE CEMENT
K033596 · Exactech, Inc. · May 2004
VERSABOND AB BONE CEMENT
K022688 · Smith & Nephew, Inc. · Apr 2004
SMARTSET GHV GENTAMICIN BONE CEMENT
K033563 · DePuy Orthopaedics, Inc. · Feb 2004
PALACOS R BONE CEMENT WITH GENTAMICIN
K030086 · Biomet, Inc. · Dec 2003
MODIFICATION TO VERSABOND BONE CEMENT
K033509 · Smith & Nephew, Inc. · Nov 2003