LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250773

    Validate with FDA (Live)

    Device Name
    Luna® Ti Interbody Fusion System
    Manufacturer
    Spinal Elements, Inc.
    Date Cleared
    2026-02-04

    (327 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    18 - 120
    Reference & Predicate Devices
    K183560,K193172,K222172
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Luna® Ti Interbody Fusion System consists of a Luna Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna Ti Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of non-operative treatment prior to receiving the Luna Ti Implant. The Luna Ti Interbody Fusion System is to be used with supplemental fixation.

    Device Description

    The Luna® Ti Interbody Fusion System devices are for use in lumbar spinal surgery. The implants have a slightly teardrop circular shape which are made of PEEK material conforming to ASTM F2026, nitinol conforming with ASTM F2063, tantalum conforming with ASTM F560, and a titanium coating conforming with ASTM F67.

    The Luna® Ti Interbody Fusion System consists of a titanium coated implant and associated accessories set of disposable and re-usable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The Luna® Ti Interbody Fusion System implant is provided pre-loaded and sterile within a single-use Insertion Tool. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space. Once the implant is in the desired position, the device is expanded into its ultimate height and forming a bone graft pocket. Teeth on the outer surfaces of the top and bottom components engage the implant into the adjacent endplates. The devices are presented with a large opening throughout the design to allow for the placement of autograft or allogenic bone graft. These devices are intended to be placed through a posterior approach.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1