Cleared Traditional

CEMEX GENTA BONE CEMENT (K033596) - FDA 510(k) Clearance

Also marketed or referenced as:
CEMEX GENTA SYSTEM BONE CEMENT

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

K033596 · Exactech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
178d
Days
Class 2
Risk

K033596 is an FDA 510(k) clearance for the CEMEX GENTA BONE CEMENT. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on May 10, 2004 after a review of 178 days - an extended review cycle.

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 Exactech, Inc. devices

Submission Details

510(k) Number K033596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2003
Decision Date May 10, 2004
Days to Decision 178 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
56d slower than avg
Panel avg: 122d · This submission: 178d
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 46
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K033596.
COBALT G HV BONE CEMENT
K051532 · Biomet, Inc. · Aug 2005
CEMEX SYSTEM GENTA FAST BONE CEMENT
K043403 · Exactech, Inc. · Dec 2004
MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
K041656 · DePuy Orthopaedics, Inc. · Jul 2004
VERSABOND AB BONE CEMENT
K022688 · Smith & Nephew, Inc. · Apr 2004
SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
K033382 · DePuy Orthopaedics, Inc. · Feb 2004
SMARTSET GHV GENTAMICIN BONE CEMENT
K033563 · DePuy Orthopaedics, Inc. · Feb 2004