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510(k) Data Aggregation

    K Number
    K252729

    Validate with FDA (Live)

    Device Name
    Universal Spinal System
    Manufacturer
    Double Medical Technology, Inc.
    Date Cleared
    2025-11-18

    (82 days)

    Product Code
    NKB,KWP,KWQ,PGM
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K040072,K113174,K222473,K963655
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Universal Spinal System is intended for non-cervical posterior and anterolateral fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following indications: 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 Universal Spinal System is 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 Universal Spinal System is intended to treat pediatric patients diagnosed with spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

    The HOBBIT Growth Connectors are indicated in patients under 10 years of age with potential for additional spinal growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis, as part of a growing rod construct.

    Device Description

    Universal Spinal System includes the HOBBIT 4.75 Spine System, HOBBIT 5.5/6.0 Spine System, HOBBIT MIS Spine System, HOBBIT 5.5/6.0 HA coated spine system and Anterior Thoracic-lumbar Spine System. Universal Spinal System consists of a variety of structures and sizes of pedicle screws, nut, rods, connectors, hook, transconnectors.

    Universal Spinal System is made from Ti-6Al-4V ELI following ASTM F136 or Ti-6Al-4V following ASTM F1472 or Co-Cr-Mo following ASTM F1537.

    The implants are provided as sterile or non-sterile, while the instruments are provided as non-sterile.

    The implants are intended for single-use only, while the instruments are reusable.

    AI/ML Overview

    N/A

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