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510(k) Data Aggregation

    K Number
    K252058

    Validate with FDA (Live)

    Device Name
    ROSA Knee System with UltraSound Imaging Platform (USIP)
    Manufacturer
    Balmoral Medical, LLC
    Date Cleared
    2026-02-06

    (220 days)

    Product Code
    OLO,ITX,IYO,KKX
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    18 - 120
    Reference & Predicate Devices
    K192388,K211656,K182964
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ROSA Knee System with USIP for use with ROSA RECON platform, is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The robotic arm placement is performed relative to the position and orientation of the femur and tibia as tracked by the ultrasound and optical systems. It is also based on the surgical plan specified by the surgeon intra-operatively on the robot user interface. To be able to perform this tracking, a virtual 3D bone model of the patient's femur and tibia are generated pre-operatively from a CT-scan of their leg.

    The ROSA Knee System with USIP is designed for use on skeletally mature patient population. It includes an ultrasound imaging system, a robotic arm, an optical sensor navigation system and accessories, surgical instruments, and a software system. It does not include a pre-operative planning feature.

    The ROSA Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: Persona® CR, Persona PS, Persona Ti-Nidium® CR, Persona Ti-Nidium PS and Persona IQ® The Smart Knee™.

    Device Description

    The ROSA® Knee System with USIP (Ultrasound Imaging Platform) is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections. The USIP device is to be used with the Zimmer Biomet ROSA Knee System to perform TKA. The USIP device provides an ultrasound-based location solution for tibia and femur replacing the use of fluted pins placed in the femur and tibia. The USIP is composed of the ultrasound acquisition box, which connects to the ROSA Knee System and two belts; femur and tibia, which contain the ultrasound transducers. NavitrackERs are mounted on the femur and tibia belts and calibrated to locate the bone relative to the robot. The belts wrap or partially wrap the thigh (femur belt) and the calf (tibia belt) of the patient. The belts image the patient's bone via the ultrasound transducers contained in the belts.

    AI/ML Overview

    N/A

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