Cleared Traditional

CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT (K021499) - FDA 510(k) Clearance

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

K021499 · DePuy Orthopaedics, Inc. · Orthopedic device
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Jul 2002
Decision
76d
Days
Class 2
Risk

K021499 is an FDA 510(k) clearance for the CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 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 July 24, 2002 after a review of 76 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K021499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2002
Decision Date July 24, 2002
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
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 K021499.
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
CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL
K021715 · Exactech, Inc. · Jun 2002
GENERATION 4 BONE CEMENT
K993836 · Biomet, Inc. · Dec 2001
CEMEX SYSTEM GUN APPLICATION VERSION
K000943 · Exactech, Inc. · Feb 2001