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510(k) Data Aggregation

    K Number
    K253660

    Validate with FDA (Live)

    Device Name
    KLS Martin Pure Pectus System
    Manufacturer
    KLS-Martin L.P.
    Date Cleared
    2026-02-20

    (92 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    2 - 21
    Reference & Predicate Devices
    K221938,K250620,K222624,K073556
    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 and other anterior chest wall deformities. 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 and other anterior chest wall deformities. 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 the Pectus Stabilizer

    2. Add "MR Conditional" to the device labeling for the Pectus Stabilizer used in conjunction with pectus bar.

    3. Expand the Indications for Use to include other anterior chest wall deformities such as Pectus Carinatum and Pectus Arcuatum

    AI/ML Overview

    N/A

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