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510(k) Data Aggregation

    K Number
    K081390
    Device Name
    BIOACTIF OSTEOTRANS INTERFENCE SCREW
    Manufacturer
    TAKIRON CO., LTD
    Date Cleared
    2008-08-12

    (85 days)

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

    TAKIRON CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioactIF OSTEOTRANS™ Interference Screw is indicated for the fixation of bone-tendon-bone grafts or soft tissue grafts during anterior / posterior cruciate ligament reconstruction surgery.
    Device Description
    The BioactIF OSTEOTRANS"M Interference Screw is a stcrile, single-use interference screw manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Screws are provided with various sizes typical of other marketed fixation devices.
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    K Number
    K073006
    Device Name
    OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
    Manufacturer
    TAKIRON CO., LTD
    Date Cleared
    2008-05-29

    (218 days)

    Product Code
    GWO, HBW, TAK
    Regulation Number
    882.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAKIRON CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSTEOTRANS™-MX Bioabsorbable Bone Fixation System is intended for use in trauma and reconstructive procedures of the craniofacial skeleton, including fracture of the cranium, infant craniofacial surgery (i.e. craniosynostosis, congenital malformations), pediatric reconstructive procedures, reconstructive procedures of the cranium, craniotomy flap fixation.
    Device Description
    The OSTEOTRANS™-MX Bioabsorbable Bone Fixation System devices are the sterile, single-use bone plates, meshes and screws manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Plates, meshes and screws are provided with various shapes and sizes typical of other marketed fixation devices. Used properly, in the presence of adequate immobilization, the OSTEOTRANS" MX Bioabsorbable Bone Fixation System devices maintain accurate alignment of bone fractures and osteotomies.
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    K Number
    K073311
    Device Name
    OSTEOTRANS-OT PIN
    Manufacturer
    TAKIRON CO., LTD
    Date Cleared
    2008-05-13

    (172 days)

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

    TAKIRON CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSTEOTRANS™-OT Pin is intended for fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses or bone grafts, for example in the fixation of apical fragments and cancellous/non-load bearing fragments in the presence of appropriate immobilization.
    Device Description
    The OSTEOTRANS™-OT Pins are the sterile, single-use bone pins manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Pins are provided with various shapes and sizes typical of other marketed fixation devices. Used properly, in the presence of adequate immobilization, the OSTEOTRANS™-OT Pins maintain accurate alignment of bone fractures and osteotomies.
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    K Number
    K073312
    Device Name
    OSTEOTRANS-OT SCREW
    Manufacturer
    TAKIRON CO., LTD
    Date Cleared
    2008-05-13

    (172 days)

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

    TAKIRON CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSTEOTRANS™-OT Screw is intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or bone grafts, including phalangeal fractures, metacarpal fractures, carpal fusion and fractures, wrist arthrodesis, distal radius fractures, olecranon fractures, radial head fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies, and correction of hallux valgus.
    Device Description
    The OSTEOTRANS™ OT Screw is a sterile, single-use bone screw manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). There are solid screws, cannulated screws and corresponding washers. Screws and washers are provided with various shapes and sizes typical of other marketed fixation devices. Used properly, in the presence of adequate immobilization, the OSTEOTRANS™-OT Screws maintain accurate alignment of bone fractures and osteotomies.
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    K Number
    K062691
    Device Name
    COMPORUS
    Manufacturer
    TAKIRON CO., LTD
    Date Cleared
    2008-04-15

    (582 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAKIRON CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Comporus™ is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Comporus™ is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with new bone during the healing process.
    Device Description
    Comporus™ is an osteoconductive biodegradable scaffold used as bone void filler. It is manufactured from a mixture of poly-D/L-lactide and hydroxyapatite and provided in granule, block and cylinder forms. They may be pressed into the surgical site by hand. Comporus™ was shown to be biocompatible. Used properly, the implant is resorbed and replaced with natural bone during the healing process. Comporus™ is sterile and intended for single use only. It is radiopaque and has the ability to be modified intraoperatively by trimming or thermal transformation to be adjusted to the shape of a defect.
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    K Number
    K061881
    Device Name
    OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
    Manufacturer
    TAKIRON CO., LTD
    Date Cleared
    2007-03-14

    (254 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAKIRON CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSTEOTRANS™-MX Bioabsorbable Bone Fixation System is indicated for use in trauma and reconstructive procedures in the craniofacial skeleton, which includes the facial cranium, mid-face, maxilla and mandible.
    Device Description
    The OSTEOTRANS™-MX Bioabsorbable Bone Fixation System devices are the sterile, single-use bone plates, meshes and screws manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Plates, meshes and screws are provided with various shapes and sizes typical of other marketed fixation devices. Used properly, in the presence of adequate immobilization, the OSTEOTRANSMAN Bioabsorbable Bone Fixation System devices maintain accurate alignment of bone fractures and osteotomies.
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