Cleared Special

SMARTSET GMV GENTAMICIN BONE CEMENT (K081163) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K081163 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
20d
Days
Class 2
Risk

K081163 is an FDA 510(k) clearance for the SMARTSET GMV GENTAMICIN BONE CEMENT. Classified as Bone Cement, Antibiotic (product code MBB), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 14, 2008 after a review of 20 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K081163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2008
Decision Date May 14, 2008
Days to Decision 20 days
Submission Type Special
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
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MBB Bone Cement, Antibiotic
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 - MBB Bone Cement, Antibiotic

All 17
Devices cleared under the same product code (MBB) and FDA review panel - the closest regulatory comparables to K081163.
StageOne Select Cement Spacer Molds for Temporary Hip Replacement
K161166 · Biomet, Inc. · Sep 2016
StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
K160071 · Biomet, Inc. · Jun 2016
Refobacin Bone Cement R
K150850 · Biomet, Inc. · Jul 2015
SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT
K063857 · Howmedica Osteonics Corp. · Feb 2007
DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT
K061144 · DePuy Orthopaedics, Inc. · Jun 2006
DEPUY CMW 1 GENTAMICIN BONE CEMENT
K053002 · DePuy Orthopaedics, Inc. · Nov 2005