Cleared Traditional

K092150 - COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT

K092150 is an FDA 510(k) clearance for COBALT MV WITH GENTAMICIN (AKA COBALT G..., manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code LOD cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K092150 · Biomet, Inc. · Orthopedic device
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Oct 2009
Decision
103d
Days
Class 2
Risk

K092150 is an FDA 510(k) clearance for the COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 27, 2009 after a review of 103 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, Inc. devices

FDA 510(k) Submission Details - K092150

510(k) Number K092150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2009
Decision Date October 27, 2009
Days to Decision 103 days
Submission Type Traditional
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
19d faster than avg
Panel avg: 122d · This submission: 103d
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 K092150.
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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 BONE CEMENT
K091608 · Biomet Manufacturing Corp · Sep 2009
SMARTSET MV BONE CEMENT
K081155 · DePuy Orthopaedics, Inc. · May 2008
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K070015 · Biomet Manufacturing Corp · Nov 2007