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510(k) Data Aggregation

    K Number
    K253331
    Device Name
    PressON Spinal Fixation System
    Manufacturer
    Nexus Spine
    Date Cleared
    2025-10-14

    (14 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K223529,K223494
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PressON Spinal Fixation System is a posterior, non-cervical pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal tumor, and failed previous fusion (pseudarthrosis).

    Device Description

    The PressON Spinal Fixation System is composed of pedicle screws, cortical screws, couplers, and rods. These components can be assembled and implanted using associated instruments via a posterior approach into the pedicles of the noncervical vertebral bodies. Components are made from Ti-6Al-4V ELI (ASTM F136).

    The purpose of this Special 510(k) submission is to gain clearance for modifications made to add an extension coupler assembly to the system.

    AI/ML Overview

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