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510(k) Data Aggregation

    K Number
    K100373
    Device Name
    TYCHE PEDICLE SCREW SYSTEM
    Manufacturer
    KYUNGWON MEDICAL CO., LTD.
    Date Cleared
    2010-06-30

    (138 days)

    Product Code
    MNH, MNI
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    KYUNGWON MEDICAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tyche® Pedicle Screw System is a non-cervical, pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, The Tyche® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
    Device Description
    The Tyche Pedicle Screw System is made up of muti-axial and standard screws, rods, locking cap, adjustable cross connectors. This system's intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. All components are made from medical grade titanium alloy (Ti-6Al-4V-ELI) by such as ASTM F136. The products are supplied clean and "NON STERILE".
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    K Number
    K092194
    Device Name
    POLYBONE DENTAL
    Manufacturer
    KYUNGWON MEDICAL CO., LTD.
    Date Cleared
    2010-06-16

    (330 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    KYUNGWON MEDICAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PolyBone® Dental is indicated to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. It is specifically for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including: ridge augmentation; sinus lifts; craniofacial augmentation; filling of defects of endodontic origin; filing of cystic defects; filling of extraction site; filling of lesions of periodontal origin; repair of traumatic defects of the alveolar ridge; filling resection defects in bone tumors; cysts or other osseous defects; and substitute for autogenous of allergenic bone grafts. PolyBone® Dental is a bone graft substitute that resorbs and it is replaced with bone during the healing process.
    Device Description
    PolyBone® Dental is a synthetic resorbable calcium phosphate bone grafting material which consists of 100% beta-tricalcium phosphate. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The multidirectional interconnected porosity ranges from 75~85% with a 200~500 um pore size. Mechanism of PolyBone Dental's bone regeneration works by bone cells resorbing dicalciumphosphate dihydrate (DCPD, brushite), which is a conversion material of ß tricalcium phosphate.
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    K Number
    K082338
    Device Name
    POLYBONE GRANULE & BLOCK
    Manufacturer
    KYUNGWON MEDICAL CO., LTD.
    Date Cleared
    2008-10-16

    (63 days)

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

    KYUNGWON MEDICAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PolyBone® Granule & Block is indicated for filling bone voids or defects that are not intrinsic to the stability of the bony structure. PolyBone® Granule & Block is to be packed into bony voids or gaps of the skeletal system (such as extremities, spine and the pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PolyBone® Granule & Block is a bone graft substitute that resorbs and it replaced with bone during the healing process.
    Device Description
    PolyBone® Granule & Block is a synthetic resorbable calcium phosphate bone void filler consisted of 99.99% beta-tricalcium phosphate, and 0.01% polyphosphate. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The multidirectional interconnected porosity ranges from 75~85% with a 200~500 um pore size. Mechanism of PolyBone® Granule & Block's bone regeneration works by bone cells resorbing polyphosphate, which is a bone regenerating palpation material. Indication for use of PolyBone® Granule & Block is a filler of bone void regions. The device is available in a variety of shape and sizes.
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    K Number
    K070012
    Device Name
    POLYBONE
    Manufacturer
    KYUNGWON MEDICAL CO., LTD.
    Date Cleared
    2007-12-27

    (358 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    KYUNGWON MEDICAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PolyBone is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defiect as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
    Device Description
    PolyBone consists of beta-tricalcium phosphate, monocalcium monobasic, calcium sulfate hemihydrate and polyphosphate. PolyBone is indicated for use as cranioplasty cement.
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