FDA 510(k)

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

Número K: K253189 · 2026-03-09

Data da decisão2026-03-09

Código do produtoMBH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2026-03-09 under 510(k) number K253189. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Zimmer, Inc.. The 510(k) number is K253189.

When did Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) receive FDA 510(k) clearance?

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

Who is the listed applicant for Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)?

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

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.

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Outros registros que listam Zimmer, Inc. como candidato(a)

K262955OsseoFit Stemless Shoulder System K261683Augment Off-Axis Instrument System K260831Z1 Hip System K251840Zimmer® Persona® Personalized Knee System K260182Avenir® Müller Stem; Avenir Complete™ Hip System K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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Dispositivos Relacionados (Código: MBH)

K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.K251840Zimmer® Persona® Personalized Knee SystemZimmer, 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 Orthopaedics

Fonte oficial

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