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510(k) Data Aggregation

    K Number
    K250403
    Device Name
    Catamaran SI Joint Fusion System
    Manufacturer
    Tenon Medical
    Date Cleared
    2025-03-21

    (37 days)

    Product Code
    OUR
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tenon Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tenon Medical Catamaran SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including: - Sacroiliac joint disruptions and degenerative sacroiliitis - To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
    Device Description
    The Catamaran SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The Catamaran SI Joint Fusion System was developed as a less invasive alternative to traditional open posterior surgical SI Joint fusion. The system consists of the Catamaran SI Joint Fixation Implant (Ti6A1-4V ELI Titanium alloy / ASTM F136) included in a reusable System Tray containing: Access, Drill and Delivery, Bone Graft Packing, and Extraction Instruments. The Catamaran SI Joint Fixation Implants are designed in various widths and lengths, and allow autologous bone graft material placement in the barrels of the implant to support SI Joint fixation and fusion. The Instrument Set includes Class II single use and reusable surgical instruments designed to facilitate placement of the implant within the sacroiliac joint using an inferior-posterior surgical approach. The implants and associated instruments are provided clean and non-sterile and are designed for steam sterilization prior to use.
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    K Number
    K231944
    Device Name
    CATAMARAN SI Joint Fusion System
    Manufacturer
    Tenon Medical, Inc.
    Date Cleared
    2023-08-24

    (55 days)

    Product Code
    OUR
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tenon Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tenon Medical CATAMARAN™ SI Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
    Device Description
    The CATAMARAN SI Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis. The CATAMARAN SI Joint Fusion System was developed as a less invasive alternative to traditional open posterior surgical SI Joint fusion. The system consists of the CATAMARAN SI Joint Fixation Implant (Ti6A1-4V ELI Titanium alloy / ASTM F136) included in a reusable System Tray containing: Access, Drill and Delivery, Bone Graft Packing, and Extraction Instruments. The CATAMARAN SI Joint Fixation Implants are designed in various widths and lengths, and allow autologous bone graft material placement in the barrels of the implant to support SI Joint fixation and fusion. The Instrument Set includes Class II single use and reusable surgical instruments designed to facilitate placement of the implant within the sacroillac joint using an inferiorposterior surgical approach. The implants and associated instruments are provided clean and non-sterile and are designed for steam sterilization prior to use.
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    K Number
    K180818
    Device Name
    Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
    Manufacturer
    Tenon Medical, Inc.
    Date Cleared
    2018-06-13

    (76 days)

    Product Code
    OUR
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tenon Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tenon Medical Catamaran Sacroiliac Joint Fixation System) is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
    Device Description
    The Tenon Medical Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) was developed as a less invasive alternative to traditional open posterior surqical SIJ fusion. The Tenon Medical Catamaran Sacroillac Joint Fixation System (CAT SIJ Fixation System) includes the Catamaran SIJ Implant and associated surgical instruments: an Access Set, a Drill/Delivery and an Accessory Set and an Extraction Set. The titanium implant consists of two hollow barrels connected by a bridge. During the procedure, autologous bone graft material is placed in the barrel of the implant to facilitate stabilization. The Catamaran SIJ Implant is available in two (2) different barrel diameters (7.5mm and 10mm) and two implant lengths (30mm and 40mm) for a total of four sizing options to fit patient anatomy. The Catamaran SIJ Implant is intended for single-use only. The implants and associated components are provided clean and non-sterile and designed for routine steam sterilization prior to use.
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