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510(k) Data Aggregation

    K Number
    K254247

    Validate with FDA (Live)

    Device Name
    OSTEOMNI SPINAL FIXATION SYSTEM
    Manufacturer
    OSTEOMNI, Inc.
    Date Cleared
    2026-02-24

    (57 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K243946
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Osteomni Spinal Fixation System is intended for use in the noncervical spine. When used as a posterior, noncervical pedicle and non- pedicle fixation system, the Osteomni Spinal Fixation System is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

    • Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
    • Spondylolisthesis.
    • Trauma (i.e. fracture or dislocation)
    • Spinal stenosis
    • Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
    • Tumor
    • Pseudoarthrosis; and failed previous fusion

    When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Osteomni Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Osteomni Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

    The Osteomni Spinal Fixation System is intended to be used with autograft and/or allograft.

    Device Description

    Osteomni Spinal fixation system is a top-loading, multiple components, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated and spondylolisthesis screws, rods (straight and curved), connectors, hooks, and setscrews. It allows surgeons and functions for use in spinal implant construction to stabilize and promote spinal fusion. The system components are supplied non-sterile, for single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136. Various sizes of these components are available to be used by a professional in a healthcare facility/ hospital.

    AI/ML Overview

    N/A

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