Cleared Traditional

K023012 - SMARTSET HV BONE CEMENT

K023012 is an FDA 510(k) clearance for SMARTSET HV 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 156-day FDA review.

K023012 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
156d
Days
Class 2
Risk

K023012 is an FDA 510(k) clearance for the 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 February 13, 2003 after a review of 156 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 DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K023012

510(k) Number K023012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2002
Decision Date February 13, 2003
Days to Decision 156 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
34d slower than avg
Panel avg: 122d · This submission: 156d
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 K023012.
DEPUY 1 GENTAMICIN BONE CEMENT
K023103 · DePuy Orthopaedics, Inc. · Sep 2003
CEMEX SYSTEM FAST
K031430 · Exactech, Inc. · May 2003
SURGICAL SIMPLEX P WITH TOBRAMYCIN
K014199 · Howmedica Osteonics Corp. · May 2003
CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT
K021499 · DePuy Orthopaedics, Inc. · Jul 2002
CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL
K021715 · Exactech, Inc. · Jun 2002
GENERATION 4 BONE CEMENT
K993836 · Biomet, Inc. · Dec 2001