Cleared Special

K081155 - SMARTSET MV BONE CEMENT

K081155 is an FDA 510(k) clearance for SMARTSET MV BONE CEMENT, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code LOD cleared through the Special 510(k) pathway after a 21-day FDA review.

K081155 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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May 2008
Decision
21d
Days
Class 2
Risk

K081155 is an FDA 510(k) clearance for the SMARTSET MV 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 May 14, 2008 after a review of 21 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

FDA 510(k) Submission Details - K081155

510(k) Number K081155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2008
Decision Date May 14, 2008
Days to Decision 21 days
Submission Type Special
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
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 K081155.
Refobacin Bone Cement R
K171540 · Biomet, Inc. · Aug 2017
COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT
K092150 · Biomet, Inc. · Oct 2009
COBALT MV BONE CEMENT
K091608 · Biomet Manufacturing Corp · Sep 2009
COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT
K070015 · Biomet Manufacturing Corp · Nov 2007
SIMPLEX P BONE CEMENT
K062553 · Stryker Orthopaedics · Jan 2007
SIMPLEX P SPEEDSET BONE CEMENT
K053198 · Howmedica Osteonics Corp. · Jan 2006