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510(k) K203557

EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing by Encore Medical, L.P. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2021
Date Received
December 7, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by Encore Medical, L.P.

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  • K252141 — AltiVate Reverse® Glenoid (August 5, 2025)
  • K251776 — EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (July 8, 2025)
  • K251241 — EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (July 2, 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)

Other clearances for product code LPH

  • K252623 — G7® Revision Acetabular System (February 4, 2026)
  • K251043 — Mpact 3D Metal Implants Extension – DMLS Technology (January 28, 2026)
  • K252067 — Velora Acetabular System (December 5, 2025)
  • K252846 — TaperSet™ Hip System (November 20, 2025)
  • K251833 — EMPOWR Acetabular® Liner Extension (November 12, 2025)
  • K251718 — ArTT Augments and Buttresses and Bone Screws (August 29, 2025)
  • K250989 — Stryker and Serf hip devices (July 25, 2025)
  • K243456 — ONVOY™ Acetabular System (June 6, 2025)
  • K242744 — Trinity EVO Acetabular Shell (June 5, 2025)
  • K242232 — Mpact 3D Metal Augments II (April 23, 2025)