Home / 510(k) Clearances / K222066

510(k) K222066

LINK MobileLink Acetabular Cup System by Waldemar Link GmbH & Co. KG — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2023
Date Received
July 13, 2022
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 Waldemar Link GmbH & Co. KG

  • K250375 — Allure Hip Stem and Intramedullary Plugs (November 5, 2025)
  • K243927 — MobileLink Acetabular Cup System - inhouse coatings (May 16, 2025)
  • K241636 — MobileLink Acetabular Cup System - Line Extension (Multiple) (November 8, 2024)
  • K231445 — LINK Embrace Shoulder System - Reverse Configuration (November 16, 2023)
  • K230471 — LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface (March 21, 2023)
  • K213770 — SP-CL Hip Stem and LCU Hip System (September 13, 2022)
  • K221794 — Vario-Cup System (July 20, 2022)
  • K211567 — BiMobile Instruments (for BiMobile Dual Mobility System) (June 3, 2022)
  • K220628 — LINK Endo-Model EVO Knee System (May 3, 2022)
  • K213675 — MP Reconstruction System (April 11, 2022)

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)