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510(k) K240418

Stryker Orthopaedics Hip Systems Labeling Update by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2024
Date Received
February 13, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

Other clearances by Howmedica Osteonics Corp., Dba Stryker Orthopaedics

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  • K252898 — Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patell (December 15, 2025)
  • K252044 — Triathlon® Total Knee System - Triathlon® Gold Femoral Components (October 24, 2025)
  • K251665 — Triathlon® Hinge Knee System (July 25, 2025)
  • K243784 — Stryker Orthopaedics Hip Devices Labeling Update (February 6, 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)
  • K233724 — 28mm/38D MDM X3 Insert for MDM Liner (March 11, 2024)

Other clearances for product code JDI

  • K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained L (July 31, 2025)
  • K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectr (October 21, 2024)
  • K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (August 2, 2024)
  • K233261 — Global Modular Replacement System (December 8, 2023)
  • K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (January 26, 2023)
  • K220216 — C-Stem AMT LE Prosthesis (July 22, 2022)
  • K213701 — Exeter® X3® RimFit® Cup (February 1, 2022)
  • K213816 — MPO Hip Instruments (January 5, 2022)
  • K210842 — VerSys Cemented Revision/Calcar (December 10, 2021)
  • K203815 — ELEOS Limb Salvage System with BioGrip (June 9, 2021)