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FDA 510(k)

Optimotion Implants Porous Metal-Backed Patella

K-Number: K220049 · 2022-03-14

ApplicantOptimotion Implants, LLC
Decision Date2022-03-14
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Optimotion Implants Porous Metal-Backed Patella is the device name listed in this FDA 510(k) record. The listed applicant is Optimotion Implants, LLC. It received FDA 510(k) clearance on 2022-03-14 under 510(k) 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. The listed applicant is Optimotion Implants, LLC. The 510(k) number is K220049.

When did Optimotion Implants Porous Metal-Backed Patella receive FDA 510(k) clearance?

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

Who is the listed applicant for Optimotion Implants Porous Metal-Backed Patella?

The FDA 510(k) record lists Optimotion Implants, LLC as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02482493All Polyethylene Versus Metal Backed Tibial Components in Knee ReplacementSUSPENDEDNCT07544264Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial ComponentRECRUITING

Other records listing Optimotion Implants, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240938The Optimotion™ Blue Plus Knee SystemK191084The Optimotion Blue Total Knee System

Related Devices (Code: MBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

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.

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