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FDA 510(k)

Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)

K-Number: K253189 · 2026-03-09

ApplicantZimmer, Inc.
Decision Date2026-03-09
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2026-03-09 under approval number K253189. 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 Porous Plasma Spray PPS Femurs)?

Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) is a medical device that received FDA 510(k) clearance on 2026-03-09. It is manufactured by Zimmer, Inc.. The 510(k) number is K253189.

When was Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) approved by the FDA?

Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) received FDA 510(k) clearance on 2026-03-09, under approval number K253189.

What company makes Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)?

Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) is manufactured by Zimmer, Inc..

What is the FDA product code for Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)?

The FDA product code for Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) is MBH.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07399574 Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples NOT_YET_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

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) 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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