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510(k) K243784

Stryker Orthopaedics Hip Devices Labeling Update by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2025
Date Received
December 9, 2024
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 Howmedica Osteonics Corp., Dba Stryker Orthopaedics

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  • K252044 — Triathlon® Total Knee System - Triathlon® Gold Femoral Components (October 24, 2025)
  • K251665 — Triathlon® Hinge Knee System (July 25, 2025)
  • K243817 — Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Po (February 6, 2025)
  • K242831 — Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Tr (December 4, 2024)
  • K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (August 2, 2024)
  • K234025 — 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads (April 24, 2024)
  • K240418 — Stryker Orthopaedics Hip Systems Labeling Update (April 12, 2024)
  • K233724 — 28mm/38D MDM X3 Insert for MDM Liner (March 11, 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)