Cleared Traditional

K091608 - COBALT MV BONE CEMENT

K091608 is an FDA 510(k) clearance for COBALT MV BONE CEMENT, manufactured by Biomet Manufacturing Corp. The device is a Class 2 Orthopedic device with product code LOD cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K091608 · Biomet Manufacturing Corp · Orthopedic device
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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

FDA 510(k) Submission Details - K091608

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
Combination Product No
PCCP Authorized No
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.

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 63
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K091608.
BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60
K123225 · Aap Biomaterials GmbH & Co. KG · Mar 2013
BONOS R GENTA 1X20 MODEL 01-0228
K123081 · Aap Biomaterials GmbH & Co. KG · Mar 2013
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
COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT
K070015 · Biomet Manufacturing Corp · Nov 2007
SIMPLEX P BONE CEMENT
K062553 · Stryker Orthopaedics · Jan 2007