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    K Number
    K221048
    Device Name
    Episealer Patellofemoral System
    Manufacturer
    Episurf Medical, Inc.
    Date Cleared
    2022-12-23

    (259 days)

    Product Code
    KRR
    Regulation Number
    888.3540
    Why did this record match?
    Applicant Name (Manufacturer) :

    Episurf Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Episealer Patellofemoral System is intended to be used in patients with osteoarthritis limited to the distal patellofemoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists. The device is intended for cemented fixation.
    Device Description
    The Episealer Patellofemoral System is a patient-individualized arthroplasty device which replaces a damaged patellofemoral joint. The subject device consists of two components: - . Episealer PF - Patellar Component ● The Episealer PF component is implanted centrally in the trochlear area of the distal femur. The Patellar Component is implanted on the backside of the patella and articulates with the Episealer PF.
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