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510(k) Data Aggregation

    K Number
    K123225
    Device Name
    BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60
    Manufacturer
    AAP BIOMATERIALS GMBH & CO. KG
    Date Cleared
    2013-03-15

    (151 days)

    Product Code
    LOD
    Regulation Number
    888.3027
    Why did this record match?
    Applicant Name (Manufacturer) :

    AAP BIOMATERIALS GMBH & CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BonOs R is intended for use in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
    Device Description
    BonOs R is a fast-setting acrylic resin for use in bone surgery. The bone cement is made of two separate sterile components. When both cement components are mixed together, they become a self hardening, radlopaque bone cement which fixes the implant and transfers stressesevenly to the bone. Bone cements in general are self-polymerizing two-component systems comprising a powder and a liquid which polymerize at room temperature immediately after they are mixed together. The major powder component is polymethyl methacrylate / acrylate. Furthermore a radio-opacifier and benzoyl peroxide as an initiator is Included. The liquid mainly consists of methyl methacrylate. It is furthermore comprised of an activator and a stabilizer to prevent premature polymerization. When the powder and liquid components are mixed together, the activator, DmpT, contained in the liquid activates the initiator in the powder component. This reaction starts the polymerization of the MMA, which is bonded with the polymer powder during ongoing polymerization. A description of polymerization technology is depictured in section 10- Executive summary, annex 10 - A. As a result, a viscous paste is obtained which can be introduced into bone using a suitable application system. Heat is generated during setting as a result of the progressive polymerization and exothermlc reaction respectively. After curing, the bone cement is able to fix the implant. The setting or curing time is greatly influenced by the temperature of the components and environment, which Is common for all acrylic bone cements.
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    K Number
    K123081
    Device Name
    BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40
    Manufacturer
    AAP BIOMATERIALS GMBH & CO. KG
    Date Cleared
    2013-03-07

    (157 days)

    Product Code
    LOD, MBB
    Regulation Number
    888.3027
    Why did this record match?
    Applicant Name (Manufacturer) :

    AAP BIOMATERIALS GMBH & CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BonOs R Genta is intended for use in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second stage of a two-stage revision after the initial infection has been cleared.
    Device Description
    BonOs R Genta is a fast-setting acrylic resin with the addition of gentamicin sulfate for use in bone surgery. The bone cement is made of two separate sterile components. When both cement components are mixed together, they become a self hardening, radiopaque bone cement which fixes the implant and transfers stresses evenly to the bone.
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    K Number
    K121876
    Device Name
    VERTECEM II CEMENT KIT
    Manufacturer
    AAP BIOMATERIALS GMBH
    Date Cleared
    2012-10-19

    (114 days)

    Product Code
    NDN, LOD, MDN
    Regulation Number
    888.3027
    Why did this record match?
    Applicant Name (Manufacturer) :

    AAP BIOMATERIALS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vertecem II Bone Cement is used for the fixation of pathological fractures of the vertebral body using Vertebroplasty or Kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
    Device Description
    Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treatment of pathological fractures of the vertebral body using a Vertebroplasty or Kyphoplasty procedure. The Vertecem II Mixing Kit consists of sterile packed components. When the cement components are mixed together, they become a self hardening, radioopaque bone cement. Bone cements in general are self-polymerizing two-component systems comprising a powder and a liquid which polymerize at room temperature immediately after they are mixed together. The major powder component is polymethyl methacrylate / acrylate. Furthermore a radio-opacifier and benzoyl peroxide as initiator is included. The liquid mainly consists of methyl methacrylate. It is furthermore comprised of an activator and a stabilizer to prevent premature polymerization. When the powder and liquid components are mixed together, the activator DmpT, contained in the liquid activates the initiator in the powder component. This reaction starts the polymerization of the MMA, which is bonded with the polymer powder during ongoing polymerization. A description of polymerization technology is depictured in section 10- Executive summary, annex 10 - D. As a result, a viscous injectable paste is obtained which can be introduced into a vertebral body using a suitable application system. Heat is generated during setting as a result of the progressive polymerization and exothermic reaction respectively. After curing the bone cement is able to stabilize the vertebral lesions and vertebral compression fractures. The setting or curing time is greatly influenced by the temperature of the components and environment, which is common for all acrylic bone cements.
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    K Number
    K090460
    Device Name
    BONOS INJECT
    Manufacturer
    AAP BIOMATERIALS GMBH
    Date Cleared
    2009-04-14

    (50 days)

    Product Code
    NDN
    Regulation Number
    888.3027
    Why did this record match?
    Applicant Name (Manufacturer) :

    AAP BIOMATERIALS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.
    Device Description
    BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a two-component system consisting of a powder and a liquid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.
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