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510(k) Data Aggregation

    K Number
    K200361
    Device Name
    Akros Scruture Anchor LisFranc Repair Kit
    Manufacturer
    Akros Medical
    Date Cleared
    2020-04-06

    (52 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Akros Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Akros Scruture Anchor LisFranc Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external fixation systems involving plates, with fracture braces and casting. Specifically, the Akros Scruture Anchor LisFranc Repair Kit is intended to provide fixation during the healing process following Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction).
    Device Description
    The Akros Scruture Anchor Lisfranc Repair Kit is a multiple-anchor orthopedic fixation device system, offered in both a stainless steel and a titanium version. The system is designed as an adjunct in repair of unstable joints, specifically as a means to provide fixation between the bones of the midfoot during the healing process following a Lisfranc injury. The design of the implant permits placement through any fracture repair plate that can accept a 4.0mm cortical screw conforming to ASTM F543-13. The anchors are provided pre-threaded and pre-loaded on their installation tools in a one-time-use pre-sterilized kit, with the Kirschner wire and drill bit needed for site preparation included.
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    K Number
    K173550
    Device Name
    Akros FibuLink™ Syndesmosis Repair Kit
    Manufacturer
    Akros Medical
    Date Cleared
    2017-12-14

    (28 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Akros Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Akros FibuLink™ Syndesmosis Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated and as an adjunct to fixation systems involving plates, with fracture braces and casting. Specifically, the Akros FibuLink™ Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
    Device Description
    The Akros FibuLink™ Syndesmosis Repair Kit is a multiple-anchor orthopedic fixation device system, offered in both a stainless steel and a titanium version. The system is designed as an adjunct in repair of unstable joints, specifically as a means to provide fixation between the tibia and fibula during the healing process following a disruption of the ankle syndesmosis. If a fracture of the fibula is present, the design of the fibula anchor permits placement through any fibula fracture repair plate that can accept a 3.5mm cortical screw conforming to ASTM F543-13. The anchors are provided pre-threaded and pre-loaded on their installation tools in a one-time-use pre-sterilized kit, with the Kirschner wire and drill bit needed for site preparation included. The current submission is for minor design modifications to the components that make up the tibia and fibula anchors and corresponding changes to some of the tools used to install them.
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    K Number
    K162805
    Device Name
    Akros Fibulink Syndesmosis Repair Kit
    Manufacturer
    Akros Medical
    Date Cleared
    2017-01-10

    (97 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Akros Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Akros FibuLink™ Syndesmosis Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated and as an adjunct to fixation systems involving plates, with fracture braces and casting. Specifically, the Akros FibuLink™ Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
    Device Description
    The Akros FibuLink™ Syndesmosis Repair Kit is a multiple-anchor orthopedic fixation device system, offered in both a stainless steel and a titanium version. The system is designed as an adjunct in repair of unstable joints, specifically as a means to provide fixation between the tibia and fibula during the healing process following a disruption of the ankle syndesmosis. If a fracture of the fibula is present, the design of the fibula anchor permits placement through any fibula fracture repair plate that can accept a 3.5mm cortical screw conforming to ASTM F543-13. The anchors are provided pre-threaded and pre-loaded on their installation tools in a one-time-use pre-sterilized kit, with the Kirschner wire and drill bit needed for site preparation included.
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