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FDA 510(k)

Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)

K-Number: K242543 · 2024-11-22

ApplicantZimmer, Inc.
Decision Date2024-11-22
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2024-11-22 under approval number K242543. 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 Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)?

Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) is a medical device that received FDA 510(k) clearance on 2024-11-22. It is manufactured by Zimmer, Inc.. The 510(k) number is K242543.

When was Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) approved by the FDA?

Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) received FDA 510(k) clearance on 2024-11-22, under approval number K242543.

What company makes Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)?

Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) is manufactured by Zimmer, Inc..

What is the FDA product code for Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)?

The FDA product code for Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) is MBH.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07607899 Virtual Reality for Pain and Well-Being in Older Adults NOT_YET_RECRUITING NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT07492797 Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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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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