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510(k) Data Aggregation

    K Number
    K251075
    Device Name
    DYNAMIS™ Implant System
    Manufacturer
    Promethean Restorative LLC
    Date Cleared
    2025-04-25

    (17 days)

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

    Promethean Restorative LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DYNAMIS™ Implant System is indicated for sacroiliac joint fusion for: - Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. - Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. The DYNAMIS™ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.
    Device Description
    The DYNAMIS™ Implant System consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. The implants are constructed from medical grade titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The implants are fully threaded with a lag design and a cannulated central threaded body. To accommodate varying patient anatomy, the DYNAMIS™ Implants are available in multiple diameters and length offerings. The implants allow for packing of autograft and allograft materials. Using the designated instrument system, two or more implants should be inserted across the SI Joint to apply a compressive force across the joint and to provide stabilization and fusion. The DYNAMIS™ implants are single use devices that are provided sterile. The DYNAMIS™ Implant System is comprised of DYNAMIS™ Screws and DYNAMIS™ TRU-NANO Screws. DYNAMIS™ TRU-NANO Screws: The surfaces of the DYNAMIS™ TRU-NANO Screws incorporate a micro- and nano-roughened surface that demonstrates the requirements for nanotechnology. The surface of the screws have been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. These screws are electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-97 nanometers. Calcium and phosphate are incorporated into the nanotube surface.
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    K Number
    K243565
    Device Name
    DYNAMIS™ SI Screw System
    Manufacturer
    Promethean Restorative LLC
    Date Cleared
    2025-02-28

    (102 days)

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

    Promethean Restorative LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DYNAMIS™ SI Screw System is indicated for sacroiliac joint fusion for: · Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroillitis. · Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. The DYNAMIS™ SI Screw System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.
    Device Description
    The DYNAMIS™ SI Screw System consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. Implants are constructed from medical grade titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The implants are fully threaded with a lag design. To accommodate varying patient anatomy, the DYNAMIS™ SI Screw Implants are available in multiple diameters and length offerings. The DYNAMIS™ SI Screw Implants consist of a cannulated central threaded body. The implants allow for packing of autograft and allograft materials. Using the designated instrument system, two or more implants should be inserted across the SI Joint to apply a compressive force across the joint and to provide stabilization and fusion. The DYNAMIS™ SI Screw implants are single use devices that are provided sterile.
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