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510(k) Data Aggregation

    K Number
    K250988

    Validate with FDA (Live)

    Device Name
    KLS Martin Pure Pectus System
    Manufacturer
    Kls- Martin L.P.
    Date Cleared
    2025-12-11

    (255 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K221938
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum. It is indicated for use in adult and pediatric (children and adolescents) populations.

    Device Description

    The KLS Martin Pure Pectus system consists of metallic implants comprised of straight and angled pectus bars and connector bars that provide support to the thoracic cavity undergoing repair for pectus excavatum. The implants are provided non-sterile in multiple sizes and are manufactured using traditional manufacturing methods. Pectus bars are manufactured from CP Titanium. Connector bars are manufactured from Ti-6Al-4V. The system also includes the necessary instruments to facilitate placement of the implants.

    The purpose of this submission is as follows:

    1. Line extension to include longer pectus bar sizes for both angled and straight pectus bars ranging greater than 380 mm and less than/equal to 500 mm

    2. Add "MR Conditional" to the device labeling for the angled and straight pectus bars ranging greater than 380 mm and less than/equal to 500 mm used in conjunction with connector bars

    AI/ML Overview

    N/A

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