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510(k) Data Aggregation

    K Number
    K260015

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-04

    (58 days)

    Product Code
    Regulation Number
    888.3060
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ANTERIS Thoracolumbar Plate System Plates are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability, or via the anterior surgical approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Trauma (i.e. fractures, including dislocation and subluxation), tumors, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, deformities (i.e. scoliosis, kyphosis, or lordosis), spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

    Device Description

    The ANTERIS Thoracolumbar Plate System is an anterior, anterolateral, or lateral plate fixation system intended for use in the thoracic, lumbar, and sacral spine (T1-S1). The plates are pre-contoured to accommodate anatomical alignment and incorporate a central vertical slot to facilitate visualization and graft placement. The ANTERIS plates are offered in standard and optional large versions. Screw back-out is prevented through the use of anti-backout caps. The system is intended to provide temporary stabilization and support to promote the development of a solid spinal fusion.

    The ANTERIS Thoracolumbar Plate System consists of plates and bone screws made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

    AI/ML Overview

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