FDA 510(k)

Sistema de Rodilla Total ATTUNE™; Manguito de Revisión Sleeve LPS™ de Adaptadores Femorales

N.º K: K253197 · 2025-11-19

Fecha de decisión2025-11-19

Código de productoJWH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2025-11-19 under 510(k) number K253197. 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 ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors?

ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors is a medical device that received FDA 510(k) clearance on 2025-11-19. The listed applicant is Depuy Ireland UC. The 510(k) number is K253197.

When did ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors receive FDA 510(k) clearance?

ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors received FDA 510(k) clearance on 2025-11-19, under 510(k) number K253197.

Who is the listed applicant for ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors?

The FDA product code for ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors is JWH.

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Otros registros que enlistan a Depuy Ireland UC como solicitante

K260480VELYS™ Robotic-Assisted Solution K261458Sistema de Rodilla Total ATTUNE; Sistema de Rodilla de Cemento Libre ATTUNE K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement K253624INHANCE™ Reverse Shoulder System K253551VELYS™ Hip Navigation K251292RECLAIM Monobloc Revision Femoral Stem

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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

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