Home / 510(k) Clearances / K231522

510(k) K231522

EMPHASYS™ Dual Mobility System by Depuy Ireland UC — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2024
Date Received
May 26, 2023
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 Depuy Ireland UC

  • K253624 — INHANCE™ Reverse Shoulder System (March 11, 2026)
  • K253551 — VELYS™ Hip Navigation (March 6, 2026)
  • K253197 — ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (November 19, 2025)
  • K251292 — RECLAIM Monobloc Revision Femoral Stem (May 23, 2025)
  • K243977 — EMPHASYS Acetabular System (January 22, 2025)
  • K243248 — INHANCE INTACT™ (December 23, 2024)
  • K242871 — ATTUNE™ Revision Hinge Knee (November 21, 2024)
  • K242084 — EMPHASYS Acetabular Shell with RapiTite HA (October 7, 2024)
  • K241000 — ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Exten (July 11, 2024)
  • K240678 — ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized (June 18, 2024)

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)