BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P000058 · Supplement: S059 · Decision Dec 4, 2015
    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(R) BONE GRAFT
    PMA Number
    P000058
    Supplement Number
    S059
    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 4, 2015
    Date Received
    April 13, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR EXPANSION OF THE APPROVED INDICATIONS FOR USE OF INFUSE BONE GRAFT TO INCLUDE IMPLANTATION WITH TWO ADDITIONAL INTERBODY FUSION DEVICES, THE PERIMETER INTERBODY FUSION DEVICE OR THE CLYDESDALE SPINAL SYSTEM, UTILIZING SELECT OPEN SURGICAL PROCEDURES IN CONJUNCTION WITH SUPPLEMENTAL SPINAL FIXATION HARDWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INFUSE BONE GRAFT/ MEDTRONIC INTERBODY FUSION DEVICE AND IS INDICATED FOR:SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR GRADE 1 RETROLISTHESIS AT THE INVOLVED LEVEL. PATIENTS RECEIVING THE INFUSE BONE GRAFT/MEDTRONIC INTERBODY FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE INFUSE BONE GRAFT/MEDTRONIC INTERBODY FUSION DEVICE. THE FOLLOWING INTERBODY DEVICES AND SURGICAL APPROACHES MAY BE USED WITH INFUSE BONE GRAFT:1) THE LT-CAGE LUMBAR TAPERED FUSION DEVICE, IMPLANTED VIA AN ANTERIOR OPEN OR AN ANTERIOR LAPAROSCOPIC APPROACH AT A SINGLE LEVEL; 2) THE INTER FIX OR INTER FIX RP THREADED FUSION DEVICE, IMPLANTED VIA AN ANTERIOR OPEN APPROACH AT A SINGLE LEVEL; 3) THE PERIMETER INTERBODY FUSION DEVICE IMPLANTED VIA A RETROPERITONEAL ANTERIOR LUMBAR INTERBODY FUSION (ALIF) AT A SINGLE LEVEL FROM L2-S1OR AN OBLIQUE LATERAL INTERBODY FUSION (OLIF) APPROACH AT A SINGLE LEVEL FROM L5-S1; AND 4) THE CLYDESDALE SPINAL SYSTEM, IMPLANTED VIA AN OLIF APPROACH AT A SINGLE LEVEL FROM L2-L5.¿

    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