BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

    PMA: P000058 · Supplement: S027 · Decision Mar 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
    Trade Name
    INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
    PMA Number
    P000058
    Supplement Number
    S027
    Device Class
    FDA Class 3
    Product Code
    NEK
    Generic Name
    Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 21, 2008
    Date Received
    November 16, 2007
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE PACKAGE INSERT: 1) INCLUSION OF WARNINGS RELATED TO LOCALIZED, TRANSIENT BONE RESORPTION AND POSSIBLE NERVE COMPRESSION DUE TO ECTOPIC BONE FORMATION PROMPTED BY A LABELING MODIFICATION REQUIRED BY THE EU AS A RESULT OF AN ANALYSIS OF REPORTED ADVERSE EVENTS; 2) INCLUSION OF CLINICAL AND ADVERSE EVENT DATA RESULTING FROM THE CLINICAL POST APPROVAL STUDY; 3) INCLUSION OF A WARNING RELATED TO ADVERSE EVENTS POTENTIALLY ASSOCIATED WITH OVER STUFFING THE SCAFFOLD COMPONENT INTO A SMALL VOLUME OR HYPERCONCENTRATING THE RECOMBINANT HUMAN PROTEIN COMPONENT; 4) INCLUSION OF REFERENCES TO PREVIOUSLY APPROVED XS AND XXS KITS; AND 5) STRENGTHENING THE LANGUAGE STATING THAT THE COMPONENTS OF THE PRODUCT MAY ONLY BE USED TOGETHER AND NOT WITH OTHER DEVICES OR COMPONENTS, E.G., SCAFFOLDS OTHER THAN THE ACS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction