FDA 510(k)

Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique

N.º K: K243574 · 2025-02-18

Fecha de decisión2025-02-18

Código de productoJWH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique 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 2025-02-18 under 510(k) number K243574. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique?

Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique is a medical device that received FDA 510(k) clearance on 2025-02-18. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K243574.

When did Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique receive FDA 510(k) clearance?

Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique received FDA 510(k) clearance on 2025-02-18, under 510(k) number K243574.

Who is the listed applicant for Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique?

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® Total Knee Systems - Kinematic Alignment Instrumentation and Technique?

The FDA product code for Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique is JWH.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Microport Orthopedics, Inc. como solicitante

K253728EVOLUTION® AM BIOFOAM® Tibial System K250444NEXUS® Hip Stem 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 los 28 dispositivos →

Dispositivos relacionados (Código: JWH)

K262057GMK ExtensionMedacta International SA K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130Sistema de Rodilla Revision ATTUNEDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.