BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P000058 · Supplement: S004 · Decision Dec 1, 2003
    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
    S004
    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
    December 1, 2003
    Date Received
    July 1, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE INCLUSION OF ADDITIONAL FUSION CAGE COMPONENT DESIGNS FOR USE WITH THE INFUSE BONE GRAFT COMPONENT. THE FOLLOWING PART NUMBERS WERE NOT INCLUDED AS PART OF THIS REQUEST: 890226, 890229, 890243, 890246, 890249, 9012426 AND 9012429; THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE FOLLOWING TRADE NAMES: INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE; INFUSE BONE GRAFT/INTER FIX THREADED FUSION DEVICE; AND INFUSE BONE GRAFT/INTER FIX RP THREADED FUSION DEVICE. FOR PURPOSES OF CLARITY, THE LT-CAGE LUMBAR TAPERED FUSION DEVICE, INTER FIX THREADED FUSION DEVCIE, AND INTER FIX RP THREADED FUSION DEVICE COMPONENTS ARE COLLECTIVELY REFERRED TO AS "INTERBODY FUSION DEVICE" FOR THE REMAINDER OF THIS APPROVAL ORDER. THE DEVICE IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L4-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY, FUNCTION DEFICIT AND/OR NEUROLOGICAL DEFICIT AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. THE INFUSE BONE GRAFT/LT-CAGE DEVICES ARE TO BE IMPLANTED VIA AN ANTERIOR OPEN OR A LAPAROSCOPIC APPROACH. THE INFUSE BONE GRAFT/INTER FIX THREADED FUSION DEVICE; AND INFUSE BONE GRAFT/INTER FIX RP THREADED FUSION DEVICE ARE TO BE IMPLANTED VIA AN ANTERIOR OPEN APPROACH ONLY. PATIENTS RECEIVING THE INFUSE BONE GRAFT/INTERBODY FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE INFUSE BONE GRAFT/INTERBODY FUSION DEVICE.

    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