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510(k) Data Aggregation

    K Number
    K252781

    Validate with FDA (Live)

    Date Cleared
    2025-12-19

    (108 days)

    Product Code
    Regulation Number
    888.3080
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MSFX Mikron Cervical PEEK Cages are made to be implanted into the appropriate vertebral section to help provide stability for spinal fusion after a diseased cervical disc producing neck and/or arm pain is removed during spinal decompression for patients who have had six weeks of non-operative treatment. Cervical PEEK Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level(C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Cervical PEEK Cages facilitate intervertebral body fusion in the cervical spine and are placed via the anterior approach and implanted with auto graft/autologous bone graft. They are to be used with supplemental fixation.

    MSFX Mikron Lumbar PEEK Cages are indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) of lumbar spine with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received at least six (6) months of prior non-operative treatment. The devices are designed to be used with supplemental fixation and autograft/ autologous bone graft to facilitate fusion for each spinal region.

    Device Description

    The MSFX Mikron Peek Cages are intervertebral body fusion devices to be implanted into appropriate cervical and lumbar spine. MSFX Mikron Peek Cages are composed of:

    • MSFX Mikron Cervical Peek Cages
    • MSFX Mikron Lumbar Peek Cages

    MSFX Mikron Cervical Peek cages are designed to maintain the height of the intervertebral space. It is used in surgical procedures where two or more vertebrae are connected or fused together to achieve fusion in spinal disorders. It supports bone fusion and is available in different shapes and sizes. The cage body is made from PEEK (ASTM F2026), and the pin, marker and screws are produced from Ti6Al4V ELI (ASTM F136). They are to be used with supplemental fixation, placed via anterior approach and implanted with autograft/autologous bone graft.

    MSFX Mikron Lumbar Peek cages are designed to maintain the height of the intervertebral space. It is used in surgical procedures where two or more vertebrae are connected or fused together to achieve fusion in spinal disorders. It supports bone fusion and is available in different shapes and sizes. The cage body is made from PEEK (ASTM F2026), and the pin, marker and expansion mechanism are produced from Ti6Al4V ELI (ASTM F136). The devices are designed to be used with supplemental fixation and autograft/ autologous bone graft to facilitate fusion for each spinal region.

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