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    K Number
    K231253
    Device Name
    Overture Orthopaedics Patellofemoral System
    Manufacturer
    Overture Resurfacing Inc.
    Date Cleared
    2023-07-07

    (67 days)

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

    Overture Resurfacing Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Overture Orthopaedics Patellofemoral System is intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.
    Device Description
    The Overture Orthopaedics Patellofemoral System is comprised of trochlear implants, and a set of ancillary instruments. The trochlear implants are titanium and feature a polished articulating surface with a titanium nitride (TiN) coating. The patellar implants are cross-linked ultra high molecular weight polyethylene (UHMWPE) and feature a titanium pin for X-ray visualization. The trochlear and patellar implants utilize cemented pegs for immediate fixation. The trochlear implants also feature porous titanium bone-contacting surfaces. The implants are provided in a variety of configurations and sizes to accommodate various patient anatomy. The trochlear implants are offered in long and round geometries. The long implants are offered in lengths ranging 25-40mm and widths ranging 20-35mm. The round trochlear implants are offered in diameters ranging 20-35mm. The patellar implants are offered in a domed geometry in diameters of 25mm and 30mm. The implants are provided gamma sterilized and individually packaged. The ancillary instruments are provided non-sterile and are to be sterilized by the end user.
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    K Number
    K221292
    Device Name
    Uni Knee Resurfacing System
    Manufacturer
    Overture Resurfacing Inc.
    Date Cleared
    2023-03-10

    (310 days)

    Product Code
    HSX
    Regulation Number
    888.3520
    Why did this record match?
    Applicant Name (Manufacturer) :

    Overture Resurfacing Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Overture Resurfacing Uni Knee Resurfacing System is intended to be used in the partial replacement of the articulating surfaces of the knee in instances where, due to compartmental degenerative disease, post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity, or previous arthroplasty, only the one side of the joint is affected. This device is intended to be used with bone cement.
    Device Description
    The Uni Knee Resurfacing System is comprised of femoral implants, and a set of ancillary instruments. The femoral implants are titanium and feature a spherical polished articulating surface with a titanium nitride (TIN) coating. The tibial implants are comprised of a titanium tibial tray with an integrated ultra-high molecular weight polyethylene (UHMWPE) tibial insert. The femoral implants and tibial trays utilize cemented pegs and porous titanium bone-contacting surfaces to allow for fixation. The femoral implant articulates against the tibial insert in a non-constrained manner. The implants are provided in a variety of configurations and sizes to accommodate various patient anatomy. Femoral implants are offered in oblong and round configurations. The oblong femoral implants are offered in lengths ranging 25-40mm and diameters ranging 17.5-27.5mm, and the round femoral implants are offered in diameters ranging 17.5-27.5mm. The tibial implants are offered in diameters ranging 17.5-22.5mm. The implants are provided gamma sterilized and individually packaged. The ancillary instruments are provided non-sterile and are to be sterilized by the end user.
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