BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Stryker Orthopaedics Hip Systems Labeling Update

    K Number: K240418 · Decision Apr 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    30
    Review Days
    59

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    Basic Information

    Device Name
    Stryker Orthopaedics Hip Systems Labeling Update
    K Number
    K240418
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Howmedica Osteonics Corp., Dba Stryker Orthopaedics
    Date Received
    February 13, 2024
    Decision Date
    April 12, 2024
    Product Code
    JDI
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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    Other Clearances by Howmedica Osteonics Corp., Dba Stryker Orthopaedics

    K Number Device Name
    K253637 Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
    K252898 Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper
    K252044 Triathlon® Total Knee System - Triathlon® Gold Femoral Components
    K251665 Triathlon® Hinge Knee System
    K243784 Stryker Orthopaedics Hip Devices Labeling Update
    K243817 Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert
    K242831 Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System
    K241716 Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
    K234025 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads
    K233724 28mm/38D MDM X3 Insert for MDM Liner
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