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510(k) K251241

EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) by Encore Medical, L.P. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2025
Date Received
April 22, 2025
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.

  • K252567 — AltiVate Reverse® ADLC Glenosphere (January 15, 2026)
  • K252974 — EMPOWR Knee (December 19, 2025)
  • K251833 — EMPOWR Acetabular® Liner Extension (November 12, 2025)
  • K252141 — AltiVate Reverse® Glenoid (August 5, 2025)
  • K251776 — EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (July 8, 2025)
  • K251184 — AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIM (May 16, 2025)
  • K241483 — ceramys™ femoral head system (February 7, 2025)
  • K233481 — AltiVate Reverse® Glenoid (May 29, 2024)
  • K222592 — AltiVate® Anatomic Shoulder AG e+™ with Markers (June 23, 2023)
  • K213387 — AltiVate® Anatomic Shoulder AG e+™ with Markers (July 7, 2022)

Other clearances for product code JWH

  • K253793 — Materialise TKA Guide System (January 6, 2026)
  • K252974 — EMPOWR Knee (December 19, 2025)
  • K253197 — ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (November 19, 2025)
  • K253314 — Freedom Infinia™ Total Knee System (October 29, 2025)
  • K253144 — Freedom® Total Knee System – Titan PCK Components (October 22, 2025)
  • K252725 — Stem Extension Line (U2 Total Knee System—PSA Type) (September 25, 2025)
  • K251554 — Materialise TKA Guide System (July 14, 2025)
  • K251776 — EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (July 8, 2025)
  • K251717 — Freedom® Total Knee System – Titanium Tibial Base Plate (June 26, 2025)
  • K242410 — NextStep Arthropedix Total Knee System (May 8, 2025)