Cleared Traditional

SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT (K053445) - FDA 510(k) Clearance

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

K053445 · DePuy Orthopaedics, Inc. · Orthopedic device
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Jan 2006
Decision
25d
Days
Class 2
Risk

K053445 is an FDA 510(k) clearance for the SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV 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 January 6, 2006 after a review of 25 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 K053445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2005
Decision Date January 06, 2006
Days to Decision 25 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
97d faster than avg
Panel avg: 122d · This submission: 25d
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 K053445.
COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT
K092150 · Biomet, Inc. · Oct 2009
SMARTSET MV BONE CEMENT
K081155 · DePuy Orthopaedics, Inc. · May 2008
SIMPLEX P SPEEDSET BONE CEMENT
K053198 · Howmedica Osteonics Corp. · Jan 2006
DEPUY CMW 1, 2 AND 3 BONE CEMENTS
K053003 · DePuy Orthopaedics, Inc. · Nov 2005
COBALT BONE CEMENT
K051496 · Biomet, Inc. · Aug 2005
COBALT G HV BONE CEMENT
K051532 · Biomet, Inc. · Aug 2005