BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Filler, Bone Void, Synthetic Peptide

    PMA: P240001 · Supplement: S001 · Decision Dec 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Filler, Bone Void, Synthetic Peptide
    Trade Name
    PearlMatrix™ P-15 Peptide Enhanced Bone Graft (PearlMatrix™ Bone Graft)
    PMA Number
    P240001
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    NOX
    Generic Name
    Filler, bone void, synthetic peptide
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 11, 2025
    Date Received
    September 8, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval to allow implantation of the product using additional open or minimally invasive surgical approaches: ALIF (anterior lumbar interbody fusion), TLIF (transforaminal lumbar interbody fusion), PLIF (posterior lumbar interbody fusion), OLIF/ATP (oblique lumbar interbody fusion/anterior to psoas) and LLIF (lateral lumbar interbody fusion); and approval to allow use of the product with titanium alloy and PEEK/titanium interbody fusion cages, as well as the original PEEK interbody fusion cages.

    Classifications

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

    Product Code Device Name
    NOX Filler, Bone Void, Synthetic Peptide