BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Filler, Bone Void, Synthetic Peptide

    PMA: P240001 · Decision Jun 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Filler, Bone Void, Synthetic Peptide
    Trade Name
    PearlMatrix™ Bone Graft
    PMA Number
    P240001
    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
    June 18, 2025
    Date Received
    January 2, 2024
    Expedited Review
    N

    Advisory Committee Statement

    PearlMatrix™ Bone Graft is indicated for intervertebral body fusion of the spine in skeletally mature patients. PearlMatrix™ Bone Graft is intended to be used in conjunction with a PEEK TLIF Fusion Device and supplemental internal spinal fixation systems cleared by the FDA for use in the lumbosacral spine. The system is to be used in patients who have had at least six months of non-operative treatment. PearlMatrix™ Bone Graft is intended for use at one level in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back and/or radicular pain of discogenic origin with degeneration of the disc confirmed by history, physical exam, and radiographic studies.

    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