BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Ankle, Uncemented, Non-Constrained

    PMA: P160036 · Supplement: S005 · Decision Sep 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Prosthesis, Ankle, Uncemented, Non-Constrained
    Trade Name
    Hintermann Series H3 Total Ankle Replacement System
    PMA Number
    P160036
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    NTG
    Generic Name
    Prosthesis, ankle, uncemented, non-constrained
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 20, 2024
    Date Received
    September 19, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    The second post-approval study (PAS002, Hintermann Series H3 TAR Performance Study) is designed to evaluate the trend in performance between each implant size and assess the outcomes of the primary surgeon of the study (accounting for approximately 80% of the registry) compared to other surgeons that are less familiar with the device. You agree to use a prospective, multicenter, single arm post approval study with data supplementation from the UK National Joint Registry (UK NJR)to evaluate the performance of the different implant sizes of the Hintermann Series H3 TAR System compared to the Hintermann Series H3 TAR System performance in the PSE cohort. Multiple investigators unfamiliar with the device will be recruited so that one surgeon does not conduct the majority of the cases and to evaluate the impact of experience on overall outcomes. You have agreed to enroll 94 US study subjects at up to 10 US sites and 407 UK study subjects at 45 UK sites and to follow these subjects for 5 years. Study subjects will undergo clinical and radiographic evaluation postoperatively at 6 weeks, 6 months, and yearly afterwards. You have agreed to take reasonable measures to avoid loss to follow-up. A follow-up rate of 85% is expected at each timepoint. You have agreed to collect and analyze information about safety, including any reoperation, revisions or removals of the Hintermann Ankle device, and effectiveness endpoints, including the American Orthopaedic Foot and Ankle Society at 2 years or more, the survivorship (absence of removal/revisions to include polyethylene revision) within 5 years, the percentage of subjects with a serious device-related adverse event other than a revision or removal within 2 years, as well as VAS score, patient satisfaction, and SF-36 for general well-being. You will also collect information about all adverse events reported for these patients, including details of the nature, onset, duration, severity, relationship to the device, and relationship to the operative procedure and outcome. Additionally, you have agreed to provide radiographic assessments of all enrolled subjects as well as a detailed explant analysis of any explanted devices during the PAS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NTG Prosthesis, Ankle, Uncemented, Non-Constrained