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510(k) Data Aggregation

    K Number
    K090763
    Device Name
    RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM
    Manufacturer
    MAKO SURGICAL CORPORATION
    Date Cleared
    2009-06-17

    (86 days)

    Product Code
    NPJ,HRY,HSX,KRR
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K082172
    Why did this record match?
    Device Name :

    RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM

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

    RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:

    • Medial unicondylar
    • Lateral unicondylar
    • Patellofemoral
    • Medial bi-compartmental (medial unicondylar and patellofemoral)
      RESTORIS MCK is for single use only and is intended for implantation with bone cement.
    Device Description

    The Restoris MCK is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). Restoris MCK Uni and Restoris MCK PF may be used in various combinations to create: a single unicompartmental femorotibial replacement for the medial or lateral side of the knee; a patellofemoral replacement; or a bicompartmental patellofemorotibial replacement for the medial side of the knee. Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

    AI/ML Overview

    The provided document is a 510(k) summary for the MAKO Surgical Corp. Restoris MultiCompartmental Knee System (Restoris MCK). This document describes the device, its components, materials, and intended use, and states its substantial equivalence to a predicate device.

    However, it does not contain any information regarding specific acceptance criteria, performance data, or detailed study methodology (like sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, or MRMC studies) related to the device's clinical or algorithmic performance.

    The document is a regulatory submission demonstrating substantial equivalence to a previously cleared device, not a report of performance testing against predefined acceptance criteria from a study.

    Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them based on the text provided. The 510(k) summary focuses on the device description and its substantial equivalence to a predicate device, as opposed to a detailed performance study with specific metrics and acceptance criteria.

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