FDA 510(k)

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella

N.º K: K243656 · 2025-07-31

SolicitanteUnited Orthopedic Corporation

Fecha de decisión2025-07-31

Código de productoMBH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2025-07-31 under 510(k) number K243656. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella?

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella is a medical device that received FDA 510(k) clearance on 2025-07-31. The listed applicant is United Orthopedic Corporation. The 510(k) number is K243656.

When did U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella receive FDA 510(k) clearance?

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella received FDA 510(k) clearance on 2025-07-31, under 510(k) number K243656.

Who is the listed applicant for U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella?

The FDA 510(k) record lists United Orthopedic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella?

The FDA product code for U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella is MBH.

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Otros registros que enlistan a United Orthopedic Corporation como solicitante

K253948Momentum Acetabular Cup System K252725Stem Extension Line (U2 Total Knee System—PSA Type)K252303Stem Extension Line (USTAR II System)K242315Resolve Modular Revision Hip Stem K243466Conformity Stem Extension Line, #0 K243024Cellbrick Knee Spacer

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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.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.

Fuente oficial

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