BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    MEDPOR Customized Implant Kit

    K Number: K254233 · Decision Mar 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    65
    Applicant Total
    21
    Review Days
    73

    Basic Information

    Device Name
    MEDPOR Customized Implant Kit
    K Number
    K254233
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Leibinger GmbH & Co KG
    Date Received
    December 29, 2025
    Decision Date
    March 12, 2026
    Product Code
    FWP
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FWP Prosthesis, Chin, Internal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FWP), ordered by most recent decision date.

    FITme Customized Silicone Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Customized Contour Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Customized Contour Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Stryker CMF MEDPOR Priority Customized Implant Kit

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Stryker CMF MEDPOR Customized Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Stryker Leibinger GmbH & Co KG

    K Number Device Name
    K253623 Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor
    K252871 Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories
    K243491 SternalPlate Expansion
    K241517 Q Guidance System; Mako Spine System;
    K241171 Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories
    K240651 MRI Universal
    K240662 Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece
    K233542 Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System
    K231599 Stryker MP, Mandible, HMMF and MMF AXS Screws
    K231208 Stryker Resorbable Fixation System
    Search all 21 clearances from Stryker Leibinger GmbH & Co KG →