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510(k) Data Aggregation

    K Number
    K253793

    Validate with FDA (Live)

    Device Name
    Materialise TKA Guide System
    Manufacturer
    Materialise N.V
    Date Cleared
    2026-01-06

    (39 days)

    Product Code
    JWH,MBH,OIY,OOG
    Regulation Number
    888.3560
    Type
    Special
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K202207,K251554
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Materialise TKA Guide System consists of hardware (Materialise TKA Guides and Models) and software (SurgiCase Knee Planner) components.

    Hardware

    • Pin Placement Guides
    The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting.

    The Materialise TKA Guides must be used in conjunction with the Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Zimmer Persona® OsseoTi® Keel Tibia, Zimmer Persona® Cemented Keel Tibia, Zimmer Persona® PPS® Femur, Vanguard® Complete Knee System, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

    The Materialise TKA Guides are intended for single use only.

    • Cut-Through Guides
    The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting and cutting of the bone.

    The Materialise TKA Guides must be used in conjunction with the Vanguard® Complete Knee System, prostheses families only.

    The Materialise TKA Guides are intended for single use only.

    • Models
    The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components.

    The Materialise TKA Models must be used in conjunction with Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Zimmer Persona® OsseoTi® Keel Tibia, Zimmer Persona® Cemented Keel Tibia, Zimmer Persona® PPS® Femur, Vanguard® Complete Knee System, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

    The Materialise TKA Models are intended for single use only.

    Software
    The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise TKA Guides and Models.

    Device Description

    The Materialise TKA Guide System is a medical device designed to be used to implant total knee prosthesis components during a total knee arthroplasty surgical procedure. This can be done by generating a presurgical knee plan and by manufacturing a patient-specific knee guide and models to transfer the knee plan to surgery.

    The subject device is a system that consists of the following two functional components:
    • A software component branded as SurgiCase Knee Planner. This software is a planning tool used to generate a personalized pre-surgical TKA plan according to either a mechanical or a restricted kinematic alignment philosophy based on patient anatomy. This initial plan can then be further edited by the surgeon.
    • Hardware components branded as Materialise TKA Guides and Models: which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Materialise TKA Guides and Models is an instrument set containing a femur and/or tibia guide(s) and bone models (optional). Both femoral and tibial guides are designed and manufactured to fit the anatomy of a specific patient. If the surgeon requests it, a bone model of the femur and/or tibia are delivered with the Materialise TKA Guides. The Materialise TKA Guides and Models assist in the intra-operative positioning of total knee replacement components. The guides assist in guiding the marking of bone before cutting and cutting of the bone. The models serve as a visual reference for the surgeon in the operating room. The Materialise TKA Guides and Models must only be used within the intended use of the compatible components (510(k) cleared, legally marketed prosthesis).

    AI/ML Overview

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