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510(k) K251043

Mpact 3D Metal Implants Extension – DMLS Technology by Medacta International S.A. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2026
Date Received
April 3, 2025
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

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  • K250477 — NextAR(TM) Spine (July 31, 2025)

Other clearances for product code LPH

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  • 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)
  • K242045 — Initia T3 Acetabular Hemispherical Shell System (April 10, 2025)