Cleared Traditional

K033382 - SMARTSET GMV ENDURANCE GENTAMICIN BONE ...

K033382 is an FDA 510(k) clearance for SMARTSET GMV ENDURANCE GENTAMICIN BONE ..., manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code LOD cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K033382 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K033382

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.

LOD Device Classification - Class 2, Special Controls

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 52
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