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FDA 510(k)

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert

K-Number: K230169 · 2023-04-06

ApplicantEncore Medical, L.P Dba Enovis
Decision Date2023-04-06
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert is a medical device manufactured by Encore Medical, L.P Dba Enovis. It received FDA 510(k) clearance on 2023-04-06 under approval number K230169. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert?

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert is a medical device that received FDA 510(k) clearance on 2023-04-06. It is manufactured by Encore Medical, L.P Dba Enovis. The 510(k) number is K230169.

When was EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert approved by the FDA?

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert received FDA 510(k) clearance on 2023-04-06, under approval number K230169.

What company makes EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert?

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert is manufactured by Encore Medical, L.P Dba Enovis.

What is the FDA product code for EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert?

The FDA product code for EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert is JWH.

Related Clinical Trials

NCT06019832 Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT03153449 ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING

Other Devices by Encore Medical, L.P Dba Enovis

K230441EMPOWR Stem Extender, 50mm

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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