FDA 510(k)

Optimotion Implants Porous Metal-Backed Patella

K-Number: K220049 · 2022-03-14

Decision Date2022-03-14

Product CodeMBH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Optimotion Implants Porous Metal-Backed Patella is a medical device manufactured by Optimotion Implants, LLC. It received FDA 510(k) clearance on 2022-03-14 under approval number K220049. 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 Optimotion Implants Porous Metal-Backed Patella?

Optimotion Implants Porous Metal-Backed Patella is a medical device that received FDA 510(k) clearance on 2022-03-14. It is manufactured by Optimotion Implants, LLC. The 510(k) number is K220049.

When was Optimotion Implants Porous Metal-Backed Patella approved by the FDA?

Optimotion Implants Porous Metal-Backed Patella received FDA 510(k) clearance on 2022-03-14, under approval number K220049.

What company makes Optimotion Implants Porous Metal-Backed Patella?

Optimotion Implants Porous Metal-Backed Patella is manufactured by Optimotion Implants, LLC.

What is the FDA product code for Optimotion Implants Porous Metal-Backed Patella?

The FDA product code for Optimotion Implants Porous Metal-Backed Patella is MBH.

Related Clinical Trials

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Other Devices by Optimotion Implants, LLC

K191084The Optimotion Blue Total Knee System K240938The Optimotion Blue Plus Knee System

Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.