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510(k) K233261

Global Modular Replacement System by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2023
Date Received
September 29, 2023
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. A.K.A. Stryker Orthopaedics

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  • K191358 — Trident II Acetabular System (October 24, 2019)
  • K182468 — Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hi (March 19, 2019)
  • K180612 — Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts (June 7, 2018)
  • K172634 — Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components (November 16, 2017)
  • K171768 — Trident® II Acetabular System (October 2, 2017)
  • K161569 — Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws (October 14, 2016)

Other clearances for product code JDI

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  • K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (August 2, 2024)
  • K240418 — Stryker Orthopaedics Hip Systems Labeling Update (April 12, 2024)
  • 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)