FDA 510(k)

EVOLUTION® AM BIOFOAM® Tibial System

Número K: K253728 · 2026-08-21

Data da decisão2026-08-21

Código do produtoMBH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EVOLUTION® AM BIOFOAM® Tibial System is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2026-08-21 under 510(k) number K253728. 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 EVOLUTION® AM BIOFOAM® Tibial System?

EVOLUTION® AM BIOFOAM® Tibial System is a medical device that received FDA 510(k) clearance on 2026-08-21. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K253728.

When did EVOLUTION® AM BIOFOAM® Tibial System receive FDA 510(k) clearance?

EVOLUTION® AM BIOFOAM® Tibial System received FDA 510(k) clearance on 2026-08-21, under 510(k) number K253728.

Who is the listed applicant for EVOLUTION® AM BIOFOAM® Tibial System?

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

What is the FDA product code for EVOLUTION® AM BIOFOAM® Tibial System?

The FDA product code for EVOLUTION® AM BIOFOAM® Tibial System is MBH.

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

K250444NEXUS® Hip Stem K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique K240452Ceramic Femoral Head K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse K233507EVOLUTION® Tibial Cones K231947EVOLUTION® Cement Keel

Ver todos os 28 dispositivos →

Dispositivos Relacionados (Código: MBH)

K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.K261462LANDMARK Total Knee SystemSmith & Nephew, 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.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Fonte oficial

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