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510(k) Data Aggregation

    K Number
    K153452
    Device Name
    Salto XT, Salto Talaris
    Manufacturer
    Tornier SAS
    Date Cleared
    2016-08-11

    (255 days)

    Product Code
    HSN
    Regulation Number
    888.3110
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K100886,K103374,K133585,K123954,K140749,K020541,K053569,K122395,K060544,K090076,K130533
    Why did this record match?
    Device Name :

    Salto XT, Salto Talaris

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Salto Talaris ankle prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatic, or degenerative arthritis. Components are intended for cemented use only.

    The Salto XT ankle prosthesis is indicated as a total ankle replacement in revision surgeries only for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Components are intended for cemented use only.

    Device Description

    The cleared Salto Talaris and the new Salto XT are intended for total ankle replacement. Both are a semiconstrained anatomical design, which reproduces the kinematics of the ankle joint. And both consist of two mating components: a metal tibial base in association with a conforming polyethylene articulating insert, and a metal talar component.

    The submission seeks clearance for:

    • the addition of new components to the Salto XT (tibial and talar components).
    • the addition of a new size and new thicknesses to the cleared range of Salto Talaris tibial inserts.

    The tibial inserts are compatible with both Salto Talaris (K060544, K090076, K130533) and the new Salto XT. The new device Salto XT has been designed to be compatible with the cleared and the new Salto Talaris tibial inserts. All Salto XT components are compatible with cleared Salto Talaris components.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for two medical devices, Salto XT and Salto Talaris ankle prostheses. This document details the FDA's decision of substantial equivalence to predicate devices, but does not describe acceptance criteria for software performance or a study proving that a device meets such criteria.

    The document describes non-clinical testing for mechanical performance, such as tibial fatigue, insert locking mechanism strength, talar stability, contact pressure, and wear. These are physical tests of the prosthesis components, not software performance.

    Therefore, I cannot extract the requested information regarding acceptance criteria and studies related to software performance from this document.

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