LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K172021

    Validate with FDA (Live)

    Device Name
    LigaPASS
    Manufacturer
    Medicrea International S.A.
    Date Cleared
    2017-08-30

    (56 days)

    Product Code
    OWI
    Regulation Number
    888.3010
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K100297,K160698
    Predicate For
    K173506,K213659
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LigaPASS is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of a solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

    • Spinal trauma surgery, used in sublaminar, or facet wiring techniques;

    • Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and kyphosis; -Spinal degenerative surgery, as an adjunct to spinal fusions.

    The LigaPASS system may also be used in conjunction with other medical implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.

    Device Description

    The LigaPASS System connects a rod to a vertebral body using a specific type of connector and a flexible band. This connector can independently tighten the rod and the bone anchor. It is comprised by a connector body, a rod set screw, a locking set screw for the band and a polyester band.

    The purpose of this submission is 1) to introduce the LigaPASS 2.0 Medial Connector and 2) to introduce the LigaPASS 2.0 Medial Open Connector.

    MATERIALS: Components in this connector are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136, pure titanium that conforms to ASTM F67 and Polyethylene Terephthalate (PET).

    AI/ML Overview

    The provided document is a 510(k) summary for the LigaPASS system, which describes its indications for use, materials, and substantial equivalence to previously cleared devices. It is for a bone fixation cerclage device, not an AI/ML device. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies, which are typical for AI/ML device approvals, is not present in this document.

    The document states:

    • No additional mechanical testing. Finite element analysis and device descriptive information were sufficient to establish the substantially equivalent mechanical performance of the subject components.

    This indicates that a study with explicit acceptance criteria for device performance, as would be expected for a novel AI/ML device, was not conducted or required for this submission. The evaluation was based on similarity to existing devices and existing mechanical data for those predicate devices.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1