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510(k) Data Aggregation

    K Number
    K170917
    Device Name
    Bi-Ostetic Bioactive Glass Foam
    Date Cleared
    2017-10-30

    (215 days)

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

    Berkeley Advanced Biomaterials

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Bi-Ostetic Bioactive Glass Foam is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone, and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
    Device Description
    The device is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) - tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible. The 45S5 glass particles are bioactive. The device is available in the form of granules, strips and putty. The composition of the granules is 60 wt% HA and 40 wt% TCP. The amount of 45S5 granules in the graft is 20 wt%. When used in the extremities, the granules and strips can be hydrated with sterile water and blood (nominally 1:1). When used in the posterolateral spine, the graft material must be hydrated with bone marrow aspirate (1:1 ratio), then mixed with autograft bone (1:1 ratio). The defect site should be filled as completely as possible. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer on the 4555 granules and the hydroxyapatite- tri-calcium phosphate granules provide an osteoconductive scaffold onto which the patient's new bone will grow. During healing, the graft particulate is absorbed and remodeled into new bone.
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    K Number
    K113791
    Device Name
    B-GENIN, R-GENIN
    Date Cleared
    2012-03-15

    (84 days)

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

    BERKELEY ADVANCED BIOMATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    B-GENIN and R-GENIN are indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous blood prior to use at the physician's discretion.
    Device Description
    B-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen and demineralized bone matrix (DBM). The device is an implant where new bone can grow. R-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen, hydroxyapatite, tri-calcium phosphate, and DBM. The device is an implant where new bone can grow.
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    K Number
    K091912
    Device Name
    B-GENIN AND R-GENIN
    Date Cleared
    2010-06-23

    (363 days)

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

    BERKELEY ADVANCED BIOMATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    B-GENIN and R-GENIN are indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should 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 created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.
    Device Description
    B-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen and demineralized bone matrix (DBM) powder. The device is an implant where new bone can grow. R-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen, demineralized bone matrix (DBM) and hydroxyapatite-tricalcium phosphate granules. The device is an implant where new bone can grow.
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    K Number
    K092046
    Device Name
    BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY
    Date Cleared
    2010-03-24

    (261 days)

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

    BERKELEY ADVANCED BIOMATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Bi-Ostetic Foam (or Putty) is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 mL.
    Device Description
    The device is a bone void filler consisting of a mineralized collagen matrix. The bovine fibrillar collagen component is biocompatible. The device provides a scaffold around which new bone can grow.
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    K Number
    K053213
    Device Name
    BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM
    Date Cleared
    2006-07-06

    (232 days)

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

    BERKELEY ADVANCED BIOMATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Bi-Ostetic Foam is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous bone marrow prior to use at the physician's discretion. In weight bearing situations, Bi-Ostetic Foam is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Bi-Ostetic Foam should not exceed 30 mL.
    Device Description
    Bi-Ostetic Foam is a bone void filler consisting of resorbable purified fibrillar collagen and resorbable hydroxyapatite/tri-calcium phosphate granules. The bovine fibrillar collagen component is biocompatible. The device provides a scaffold around which new bone can grow.
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    K Number
    K051914
    Device Name
    GENEROS 80, GENEROS 60
    Date Cleared
    2005-11-03

    (112 days)

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

    BERKELEY ADVANCED BIOMATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GenerOs™ is an osteoconductive bone substitute shaped as granules or blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules or blocks may be pressed into the void or into the surgical site by hand. The GenerOs™ granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. GenerOs™ is biocompatible and resorbs in the body as bone ingrowth occurs.
    Device Description
    GenerOs (60 or 80) is a sterile osteoconductive bone void filler. This synthetic bone graft comes in the shape of granules or blocks. GenerOs (60 or 80) is supplied sterile for single patient use only. It is biocompatible and resorbs in the human body as bone ingrowth occurs when applied according to its indications for use. The implant is bioresorbable and radio-opaque.
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    K Number
    K051695
    Device Name
    MARROW PLUS (M+)
    Date Cleared
    2005-07-19

    (26 days)

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

    BERKELEY ADVANCED BIOMATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Marrow Plus (M+™) is intended for use as a system for the aspiration of bone marrow, autologous blood, plasma or other blood components. Prior to use, the syringe is either pre-filled or filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). This system provides the surgeon with a convenient way to syringe bone graft material and deliver the material to the orthopaedic surgical site. M+ may be pre-filled with synthetic bone substitute (Bi-Ostetic, Cem-Ostetic, Tri-Ostetic, BioPlus, GenerOs) shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are pressed into the void or into the surgical site by hand. The granules or blocks are not intended to provide structural support. The material is radio-opaque. It is biocompatible and resorbs in the body as bone ingrowth occurs.
    Device Description
    Not Found
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    K Number
    K050666
    Device Name
    GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES
    Date Cleared
    2005-04-11

    (28 days)

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

    BERKELEY ADVANCED BIOMATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GenerOs™ is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules or blocks may be pressed into the void or into the surgical site by hand. The GenerOs™ granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. GenerOs™ is biocompatible and resorbs in the body as bone ingrowth occurs.
    Device Description
    GenerOs™ is a sterile osteoconductive bone void filler composed of ß-TCP. This synthetic bone graft comes in the shape of granules or blocks. GenerOs™ is supplied sterile for single patient use only. GenerOs™ is biocompatible and resorbs in the human body as bone ingrowth occurs when applied according to its indications for use. The implant is bioresorbable and radio-opaque.
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    K Number
    K042636
    Device Name
    BIOPLUS
    Date Cleared
    2004-12-14

    (78 days)

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

    BERKELEY ADVANCED BIOMATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BioPlus is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules or blocks may be pressed into the void or into the surgical site by hand. The BioPlus granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. BioPlus is biocompatible and resorbs in the body as bone ingrowth occurs.
    Device Description
    BioPlus is a sterile osteoconductive bone void filler. It consists of a formulation of calcium-based compounds. This synthetic bone graft comes in the shape of granules or blocks. BioPlus is supplied sterile for single patient use only. BioPlus is biocompatible and resorbs in the human body as bone ingrowth occurs when applied according to its indications-for-use. The implant is bioresorbable and radio-opaque.
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    K Number
    K041889
    Device Name
    TRI-OSTETIC
    Date Cleared
    2004-08-19

    (38 days)

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

    BERKELEY ADVANCED BIOMATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Tri-Ostetic is an osteoconductive putty that is intended to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The Tri-Ostetic paste set in situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque Tri-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
    Device Description
    Tri-Ostetic is a sterile osteoconductive bone void filler. Tri-Ostetic consists of a pre-measured formulation of distilled water and calcium-based compounds in a container that can be used to prepare a putty. Tri-Ostetic forms a paste when mixed with sterile distilled water. Both powder and water are supplied pre-measured in separate containers. The putty can be shaped into an implant or inserted into a syringe and injected into the surgical site (i.e., bony voids or gaps of skeletal system). Tri-Ostetic powder and the water are supplied sterile for single patient use only. Tri-Ostetic is biocompatible, bioresorbable and radio-opaque. Tri-Ostetic resorbs in the human body as bone ingrowth occurs when applied according to its indications for use.
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