Vanguard XP Knee System
K-Number: K153657 · 2016-05-10
ApplicantBiomet, Inc.
Decision Date2016-05-10
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Vanguard XP Knee System is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2016-05-10 under approval number K153657. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Vanguard XP Knee System?
Vanguard XP Knee System is a medical device that received FDA 510(k) clearance on 2016-05-10. It is manufactured by Biomet, Inc.. The 510(k) number is K153657.
When was Vanguard XP Knee System approved by the FDA?
Vanguard XP Knee System received FDA 510(k) clearance on 2016-05-10, under approval number K153657.
What company makes Vanguard XP Knee System?
Vanguard XP Knee System is manufactured by Biomet, Inc..
What is the FDA product code for Vanguard XP Knee System?
The FDA product code for Vanguard XP Knee System is MBH.
Other Devices by Biomet, Inc.
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K162424Ulna Plating System
K161166StageOne Select Cement Spacer Molds for Temporary Hip Replacement
K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
K161190G7 Dual Mobility System, Active Articulation System
K160058Biomet Variable Pitch Compression Screw System
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K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.