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510(k) Data Aggregation

    K Number
    K063461
    Device Name
    ANOVA CONTAINMENT DEVICE
    Manufacturer
    ANOVA CORPORATION
    Date Cleared
    2009-08-13

    (1002 days)

    Product Code
    EZX, KWO
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    EZX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anova Containment Device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
    Device Description
    The Anova Containment Device is a flexible, synthetic composite implantable mesh. It includes a polyester mesh component connected by a mono-filament suture to a porous expanded polytetrafluoroethylene or "ePTFE" component. This ePTFE component is placed between the polyester mesh and the overlying soft tissues. The ePTFE component is not anchored to the disc. The Anova Containment Device is attached to the spine with four suture anchors (two fastened to the vertebra above and two fastened to the vertebra below the disc). The sutures from the anchors overlay the mesh and hold it against the vertebral body and to reinforce the mesh against pressure from the graft material.
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    K Number
    K014200
    Device Name
    OPTIMESH
    Manufacturer
    SPINEOLOGY, INC.
    Date Cleared
    2003-11-26

    (705 days)

    Product Code
    EZX
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    EZX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OptiMesh is intended to maintain the relative position of bone graft material (such as autograft or allograft) within a vertebral body defect (e.g. tumor) that does not impact the stability of the vertebral body and does not include the vertebral endplates.
    Device Description
    OptiMcsh is a sterile, three-dimensional surgical mesh container made of knitted polyester yarn and offered in a range of sizes. The device is packaged in double Tyvek/Mylar pouches and a cardboard carton, and terminally sterilized.
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    K Number
    K032344
    Device Name
    THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330
    Manufacturer
    IMPLEX CORP.
    Date Cleared
    2003-10-02

    (64 days)

    Product Code
    EZX
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    EZX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures, such as pelvic reconstruction, acetabular reconstruction, cement restriction and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel® Trabecular Metal Reconstruction system may be used with bone graft.
    Device Description
    The Hedrocel Trabecular Metal Reconstructive System is manufactured wholly of Hedrocel porous tantalum, the same material that comprises numerous medical devices intended for use in orthopedic applications. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. The devices in this line extension are wedge shaped and contoured so as to fit a variety of anatomical bone structures. The devices are available in small, medium and large sizes, with the cross-sectional dimensions being 0.52in x 0.88in for the small size; 0.58in x 0.96in for the medium size, and 0.62in x 1.06in for the large size. Each size consists of varying heights ranging from 2mm - 8mm in 2mm increments. There is a consistent inclination angle of 10 degrees along the length in all size ranges. A secondary inclination angle along the width ranges from 20-35 degrees in 5-degree increments. The resultant geometry is a bi-plane wedge. The devices have a 6mm central hole for optional bone graft placement. A tapered slot is provided for implantation instrumentation.
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    K Number
    K032282
    Device Name
    MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
    Manufacturer
    IMPLEX CORP.
    Date Cleared
    2003-08-21

    (28 days)

    Product Code
    EZX
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    EZX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, cement restriction, and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel Trabecular Metal Reconstruction System may also be used with bone graft.
    Device Description
    Hedrocel Trabecular Metal Reconstruction The System is manufactured wholly of Hedrocel porous tantalum. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. This line extension adds components with a variety of cross-sections and heights to the Hedrocel Trabecular Metal Reconstruction System.
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    K Number
    K024169
    Device Name
    MACROPORE OS RECONSTRUCTION
    Manufacturer
    MACROPORE BIOSURGERY, INC.
    Date Cleared
    2003-07-01

    (195 days)

    Product Code
    EZX, HRS, HWC, MAI
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    EZX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The flat Protective Sheets with pore sizes up to 2.5mm are also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving: - Long bones - Flat bones - Short bones - · Irregular bones - · Appendicular skeleton - Thorax When used alone (without traditional rigid fixation), the MacroPore OS Reconstruction System is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving: - · Tumor resections where bone strength has not been compromised - Iliac crest harvests - Ribs (excluding multiple segmental defects such as those found in flail chest) This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.
    Device Description
    MacroPore OS Reconstruction System is a resorbable graft containment system composed of various sized porous sheet and sleeves, non-porous sheets and associated fixation screws and tacks manufactured from polylactic acid (PLA). The MacroPore OS Reconstruction System is composed of MacroPore OS Reconstruction System Protective Sheets, MacroPore OS Reconstruction System Protective Sleeves, and MacroPore OS Reconstruction Screws and Tacks. The MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore OS Reconstruction System to the desired shape or size. MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves are fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore OS Reconstruction System Protective Sheets can be rolled into a tube or used as a flat sheet. The MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves can be used either alone or in conjunction with internal bone fixation devices such as plates and screws, which also can serve to fixate the MacroPore OS Reconstruction System and prevent dislocation. The MacroPore OS Reconstruction System Tacks range in size from 1.7mm to 2.2mm in diameter with lengths from 3.6mm to 5.6mm and the MacroPore OS Reconstruction System Screws range in size from 2.0mm to 4.75mm in diameter with lengths from 3.35mm to 30mm. The MacroPore OS Reconstruction System Protective Sheet is provided in sheets of 25 x 25 mm to 160 x 200 mm. The MacroPore OS Reconstruction System Protective Sleeves are provided in lengths of 150mm to 5mm with inner diameters that range from 5mm up to 40mm. The MacroPore Reconstruction System Protective Sleeves are provided in circular, square, trapezoidal, and parabolic shapes. The MacroPore OS Reconstruction System Protective Sleeves are provided with and without serrated edges and / or tapered end(s) for ease of surgical installation. The MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves are provided with and without macroporous holes. The pore size ranges from 1.7mm to 4.0mm in diameter, with pores distributed randomly or uniformly throughout the sheet/sleeve in an offset or aligned pattern. The thickness of the MacroPore OS Reconstruction System Protective Sheets ranges from 0.5mm to 5.0mm according to the orthopedic region to be treated. The thickness of the MacroPore OS Reconstruction System Protective Sleeves ranges from 0.8mm to 5.0mm according to the orthopedic region to be treated.
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    K Number
    K023882
    Device Name
    THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
    Manufacturer
    IMPLEX CORP.
    Date Cleared
    2003-02-19

    (90 days)

    Product Code
    EZX
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    EZX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, cement restriction, and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel Trabecular Metal Reconstruction System may also be used with bone graft.
    Device Description
    The Hedrocel Trabecular Metal Reconstructive System is manufactured wholly of Hedrocel porous tantalum. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. The Hedrocel Trabecular Metal Reconstructive System has oval cross-sectional geometries of 11mm by 14mm and 21mm by 32mm and is available in height options ranging from 8mm to 62mm. The superior and inferior faces of the implant are canted (included angle of 7 degrees) to provide for initial stability and to facilitate implantation.
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    K Number
    K020853
    Device Name
    NUVASIVE MESH
    Manufacturer
    NUVASIVE, INC.
    Date Cleared
    2002-06-13

    (90 days)

    Product Code
    EZX
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    EZX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NuVasive® Mesh is indicated for use in the reinforcement of weak bony tissue in orthopedic procedures.
    Device Description
    The NuVasive® Mesh is a rhombic pattern surgical mesh device intended for the reinforcement of weak bony tissue during orthopedic surgical procedures. The implant is available in preformed round or oval cylinders, in a variety of different sizes.
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    K Number
    K983766
    Device Name
    SYNTHES SYNMESH
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    1998-12-18

    (53 days)

    Product Code
    EZX
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    EZX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indication for use is for the reinforcement of weak bony tissue in orthopedic procedures.
    Device Description
    The Synthes SynMesh consists of both flat mesh and preformed round and oval shaped mesh cylinders. The flat mesh is intended to be customized to a design and geometry that satisfies the patients anatomical defect. In addition, rings and screws are available to reinforce the cylinders. The preformed cylinders are offered in various sizes. The mesh and preformed cylinders are manufactured from commercially pure titanium (ASTM F67). Indication for use is in reinforcement of weak bony tissue in orthopedic surgical procedures.
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