FDA 510(k)

EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)

Número K: K251776 · 2025-07-08

Data da decisão2025-07-08

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2025-07-08 under 510(k) number K251776. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)?

EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) is a medical device that received FDA 510(k) clearance on 2025-07-08. The listed applicant is Encore Medical L.P.. The 510(k) number is K251776.

When did EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) receive FDA 510(k) clearance?

EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) received FDA 510(k) clearance on 2025-07-08, under 510(k) number K251776.

Who is the listed applicant for EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)?

The FDA 510(k) record lists Encore Medical L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)?

The FDA product code for EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) is JWH.

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Outros registros que listam Encore Medical L.P. como candidato(a)

K252567AltiVate Reverse® ADLC Glenosphere K252974EMPOWR Knee K251833EMPOWR Acetabular® Liner Extension K252141AltiVate Reverse® Glenoid K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)K251184Sistema de Ombro Inversa AltiVate; Sistema de Ombro RSP; Sistema de Ombro SMR; Sistema Fêmur PRIMA; Sistema Glenoid PRIMA

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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.K262130ATTUNE Sistema de Quadril de RevisãoDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Fonte oficial

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