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510(k) Data Aggregation

    K Number
    K231714
    Device Name
    Graftys Quickset
    Manufacturer
    Date Cleared
    2023-07-12

    (30 days)

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

    Graftys

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GRAFTYS® QUICKSET is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS® QUICKSET is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during process.
    Device Description
    GRAFTYS® QUICKSET is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment missing syringe which is pre-filled with a powder (calcium phosphate salts and HPMC) and with a phosphate-based (Na2HPO4) aqueous solution. When these two components are mixed in the syringe, an injectable calcium-deficient apatite is athermally formed. In vivo, this apatite, which hardens, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS® QUICKSET is a sterile, nonpyrogenic, single-use product.
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    K Number
    K093343
    Device Name
    GRAFTY QUICKSET
    Manufacturer
    Date Cleared
    2010-04-22

    (178 days)

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

    GRAFTYS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GRAFTYS® Quickset is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS® Quickset is intended to be placed or injected 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 created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.
    Device Description
    GRAFTYS®QUICKSET is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment mixing syringe which is pre-filled with a powder (calcium phosphate salts and HPMC) and with a phosphate-based (Na2HPO4) aqueous solution. When these two components are mixed in the syringe, an injectable calcium-deficient apatite is athermally formed. Invivo, this apatite which hardens in approximately 2min, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS®QUICKSET is a sterile single-use product.
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    K Number
    K082498
    Device Name
    GRAFTYS HBS
    Manufacturer
    Date Cleared
    2009-02-25

    (180 days)

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

    GRAFTYS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GRAFTYS®HBS is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS®HBS is intended to be placed or injected into bony voids or gaps of the skeletal system (the extremities and pelvis).These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.
    Device Description
    GRAFTYS®HBS is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment mixing syringe which is pre-filled with a powder (calcium phosphate salts and HPMC) and with a phosphate-based (Na2HPO4) aqueous solution. When these two components are mixed in the syringe, 8cc of an injectable calcium-deficient apatite is athermally formed. In-vivo, this apatite which hardens in approximately 15 min, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS®HBS is a sterile, non-pyrogenic, single-use product.
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    K Number
    K082286
    Device Name
    BIOACTYS
    Manufacturer
    Date Cleared
    2009-02-24

    (197 days)

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

    GRAFTYS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Bioactys® is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. These defects may be surgically created osseous or defects created from traumatic injury to bone.
    Device Description
    BIOACTYS® is a sterile single use bioresorbable bone void filling substitute. BIOACTYS® is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate. Following placement in the bony voids or gap, BIOACTYS® resorbs and is replaced with bone during the healing process. BIOACTYS® is available in the form of granules.
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    K Number
    K073064
    Device Name
    GRAFTYS BCP
    Manufacturer
    Date Cleared
    2008-03-11

    (133 days)

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

    GRAFTYS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GRAFTYS®BCP is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. GRAFTYS BCP has limited initial mechanical properties. Therefore rigid fixation techniques may often be recommended. GRAFTYS®BCP can be used with autograft as a bone graft extender. In addition when used with appropriate opening osteotomy system devices, plates and screws, GRAFTYS®BCP is intended to be used as a bone void filler in femoral or tibial osteotomies
    Device Description
    GRAFTYS®BCP is a sterile single use bioresorbable bone void filling substitute. GRAFTYS®BCP is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate. Following placement in the bony voids or gap, GRAFTYS®BCP resorbs and is replaced with bone during the healing process. GRAFTYS®BCP is available in the form of granules, sticks, cylinders and wedges.
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