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FDA 510(k)

The Optimotion™ Blue Plus Knee System

K-Number: K240938 · 2024-06-27

ApplicantOptimotion Implants, LLC
Decision Date2024-06-27
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Optimotion™ Blue Plus Knee System 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 2024-06-27 under 510(k) number K240938. 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 The Optimotion™ Blue Plus Knee System?

The Optimotion™ Blue Plus Knee System is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Optimotion Implants, LLC. The 510(k) number is K240938.

When did The Optimotion™ Blue Plus Knee System receive FDA 510(k) clearance?

The Optimotion™ Blue Plus Knee System received FDA 510(k) clearance on 2024-06-27, under 510(k) number K240938.

Who is the listed applicant for The Optimotion™ Blue Plus Knee System?

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 The Optimotion™ Blue Plus Knee System?

The FDA product code for The Optimotion™ Blue Plus Knee System is MBH.

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.

K220049Optimotion Implants Porous Metal-Backed PatellaK191084The 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

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

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