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510(k) K230169

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert by Encore Medical, L.P Dba Enovis — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2023
Date Received
January 20, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

Other clearances by Encore Medical, L.P Dba Enovis

  • K230441 — EMPOWR Stem Extender, 50mm (March 17, 2023)

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  • K252725 — Stem Extension Line (U2 Total Knee System—PSA Type) (September 25, 2025)
  • K251554 — Materialise TKA Guide System (July 14, 2025)
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  • K251241 — EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (July 2, 2025)
  • K251717 — Freedom® Total Knee System – Titanium Tibial Base Plate (June 26, 2025)