Cleared Traditional

K023103 - DEPUY 1 GENTAMICIN BONE CEMENT

K023103 is an FDA 510(k) clearance for DEPUY 1 GENTAMICIN BONE CEMENT, 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 376-day FDA review.

K023103 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
376d
Days
Class 2
Risk

K023103 is an FDA 510(k) clearance for the DEPUY 1 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 September 29, 2003 after a review of 376 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K023103

510(k) Number K023103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2002
Decision Date September 29, 2003
Days to Decision 376 days
Submission Type Traditional
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
254d slower than avg
Panel avg: 122d · This submission: 376d
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 K023103.
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
CEMEX SYSTEM FAST
K031430 · Exactech, Inc. · May 2003
SURGICAL SIMPLEX P WITH TOBRAMYCIN
K014199 · Howmedica Osteonics Corp. · May 2003
SMARTSET HV BONE CEMENT
K023012 · DePuy Orthopaedics, Inc. · Feb 2003