Cleared Traditional

COBALT MV BONE CEMENT (K091608) - FDA 510(k) Clearance

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

K091608 · Biomet Manufacturing Corp · Orthopedic device
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Optimized for regulatory review, auditing and printing
Sep 2009
Decision
106d
Days
Class 2
Risk

K091608 is an FDA 510(k) clearance for the COBALT MV BONE CEMENT. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on September 17, 2009 after a review of 106 days - within the typical 510(k) review window.

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 Biomet Manufacturing Corp devices

Submission Details

510(k) Number K091608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2009
Decision Date September 17, 2009
Days to Decision 106 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 122d · This submission: 106d
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 47
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K091608.
Biomet Bone Cement R
K172408 · Biomet, Inc. · Oct 2017
Refobacin Bone Cement R
K171540 · Biomet, Inc. · Aug 2017
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
SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT
K053445 · DePuy Orthopaedics, Inc. · Jan 2006