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510(k) Data Aggregation

    K Number
    K051656
    Device Name
    OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM
    Manufacturer
    OSTEOBIOLOGICS, INC.
    Date Cleared
    2005-10-25

    (126 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOBIOLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OCT (Osteochondral Transplant) Comprehensive System is indicated for arthroscopic (Knee and Ankle) and open osteochondral grafting for the treatment of osteochondral (cartilage) defects.
    Device Description
    The OCT (Osteochondral Transplant) Comprehensive System is a kit composed of several orthopedic surgical instruments. These instruments include Drill Sleeve Cap, Drills, Toothed Core Sleeve and Plunger, Obturators, Sizers, Drill Handle, Ruler and Drill Sleeves and Sterilization Tray. All instruments are composed of stainless steel and/or injection molded plastic. The instruments range in size from 3 to 11 mm.
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    K Number
    K041382
    Device Name
    POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
    Manufacturer
    OSTEOBIOLOGICS, INC.
    Date Cleared
    2005-06-17

    (388 days)

    Product Code
    JDK
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOBIOLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PolyGraft™ BGS Cement Restrictor is indicated for use as a bone cement flow restrictor plug in the femur, tibia, and/or humerus.
    Device Description
    Not Found
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    K Number
    K043172
    Device Name
    TRUGRAFT BGS SYRINGE, MODEL 600-041
    Manufacturer
    OSTEOBIOLOGICS, INC.
    Date Cleared
    2005-01-07

    (52 days)

    Product Code
    FMF, MQV
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOBIOLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TruGraft™ BGS Syringe is indicated for the aspiration of fluids, such as autologous blood, plasma or other blood components with preloaded bone graft substitute.
    Device Description
    The TruGraft™ BGS Syringe is a device that can be filled with OsteoBiologics, Inc. products: PolyGraft® BGS or PolyGraft® TCP (K030288 and K033707 respectively) or other bone graft substitute. The TruGrafTM BGS Syringe can be provided as a kit configuration. The convenience kit provides the TruGrafTM BGS Syringe loaded (filled) with a variety of bone graft substitutes. The TruGrafi™ BGS Syringe is a standard piston syringe that consists of a barrel, plunger and removable end cap. The distal end of the barrel is threaded to allow connection to adapters. While without the attachment, the open end allows for filling of the bone graft material. A cap is available to seal the end of the barrel, enclosing the syringe contents. The piston/plunger assembly is used to expel contents or facilitate in the collection into the barrel of the syringe.
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    K Number
    K040047
    Device Name
    POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
    Manufacturer
    OSTEOBIOLOGICS, INC.
    Date Cleared
    2004-12-17

    (340 days)

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

    OSTEOBIOLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PolyGraft™ BGS is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraff™ BGS is intended to 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 with bone during the healing process. The PolyGraft™ BGS may be combined with autogenous blood products, such as platelet rich plasma, and/or sterile fluids, such as saline or Ringer's solution. The addition of these autogenous products does not alter the performance of the device.
    Device Description
    PolyGraft™ BGS is manufactured using a blend of poly(D,L-lactide-coglycolide), calcium sulfate, polyglycolide fibers and surfactant. The PolyGrafi™ BGS will be provided in a variety of shapes and sizes ranging from small, porous granules to preformed cylindrical plugs.
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    K Number
    K033707
    Device Name
    POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX
    Manufacturer
    OSTEOBIOLOGICS, INC.
    Date Cleared
    2004-08-16

    (264 days)

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

    OSTEOBIOLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PolyGraft™ TCP is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraft™ TCP is intended to 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 with bone during the healing process.
    Device Description
    PolyGraft™ TCP is manufactured using a blend of poly(D,L-lactide-coglycolide), tricalcium phosphate, polyglycolide fibers and surfactant. The PolyGraff™ TCP will be provided in a variety of shapes and sizes ranging from small, porous granules to preformed cylindrical plugs.
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    K Number
    K032673
    Device Name
    IMMIX PLASTIFILM
    Manufacturer
    OSTEOBIOLOGICS, INC.
    Date Cleared
    2003-10-02

    (34 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOBIOLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMMIX™ PlastiFilm is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
    Device Description
    The IMMIX™ PlastiFilm is manufactured using poly(D,L-lactide-coglycolide) polymer and triethyl 2-acetylcitrate or tributyl 2-acetylcitrate. The device will be provided in sheets of 10 mm x 10 mm to 120 mm x 120mm. Other shapes and sizes will be provided as needed for particular surgical procedures. Additionally, the device can be cut with scissors to obtain desired shapes and sizes. The thickness of the IMMIX™ PlastiFilm will range from 50 to 300 microns, according to the region to be treated, and will be provided with and without macroporous holes. The holes will range from 100 microns to 1000 microns in diameter. The holes may be aligned, offset, or random patterns. The borders of the sheets may be aligned with the holes to attach suture material.
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    K Number
    K030288
    Device Name
    POLYGRAFT BONE GRAFT SUBSTITUTE
    Manufacturer
    OSTEOBIOLOGICS, INC.
    Date Cleared
    2003-07-17

    (170 days)

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

    OSTEOBIOLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PolyGraft™ BGS is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraft™ BGS is intended to 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 with bone during the healing process.
    Device Description
    PolyGraft™ BGS is manufactured using a blend of poly(D,L-lactide-coglycolide), calcium sulfate, polyglycolide fibers and surfactant. The PolyGraft™ BGS will be provided in a variety of shapes and sizes ranging from small, porous granules to preformed cylindrical plugs.
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    K Number
    K024199
    Device Name
    IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP
    Manufacturer
    OSTEOBIOLOGICS, INC.
    Date Cleared
    2003-03-14

    (84 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOBIOLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMMIX™ Thin Film is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
    Device Description
    The IMMIX™ Thin Film is manufactured using poly(D,L-lactide-coglycolide) polymer and will be provided in sheets of 10 mm to 120 mm x 120mm. Other shapes and sizes will be provided as needed for particular surgical procedures. Additionally, the device can be cut with scissors to obtain desired shapes and sizes. The thickness of the IMMX™ Thin Film will range from 50 to 300 microns, according to the region to be treated, and will be provided with and without macroporous holes. The holes will range from 100 microns to 1000 microns in diameter. The holes may be aligned, offset, or random patterns. The borders of the sheets may be aligned with the holes to attach suture material.
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    K Number
    K013429
    Device Name
    ACTAEON PROBE
    Manufacturer
    OSTEOBIOLOGICS, INC.
    Date Cleared
    2002-01-11

    (87 days)

    Product Code
    NGR
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOBIOLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACTAEON™ Probe arthroscopic cartilage stiffness tester is indicated for an arthroscopic in vivo point measurement of articular cartilage stiffness in humans. The ACTAEON™ Probe can be used arthroscopically or in open joint procedures.
    Device Description
    The ACTAEON™ Probe is a hand-held device which when activated by the user measures the reaction force (resistance) of articular cartilage against a known rate and force of indentation applied by the disposable indenting tip of the device.
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