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FDA 510(k)

The Optimotion Blue Total Knee System

K-Number: K191084 · 2020-04-07

ApplicantOptimotion Implants, LLC
Decision Date2020-04-07
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Optimotion Blue Total Knee System is a medical device manufactured by Optimotion Implants, LLC. It received FDA 510(k) clearance on 2020-04-07 under approval number K191084. 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 Total Knee System?

The Optimotion Blue Total Knee System is a medical device that received FDA 510(k) clearance on 2020-04-07. It is manufactured by Optimotion Implants, LLC. The 510(k) number is K191084.

When was The Optimotion Blue Total Knee System approved by the FDA?

The Optimotion Blue Total Knee System received FDA 510(k) clearance on 2020-04-07, under approval number K191084.

What company makes The Optimotion Blue Total Knee System?

The Optimotion Blue Total Knee System is manufactured by Optimotion Implants, LLC.

What is the FDA product code for The Optimotion Blue Total Knee System?

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

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED

Related PubMed Literature

PMID: 41209898 Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty. Cureus (2025) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 29258356 Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system. Accountability in research (2018) PMID: 28280294 Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices. Journal of health care finance (2016)

Other Devices by Optimotion Implants, LLC

K220049Optimotion Implants Porous Metal-Backed Patella 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

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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