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510(k) Data Aggregation

    K Number
    K241027
    Device Name
    Permatage Settable Bone Putty
    Manufacturer
    Orthocon, Inc.
    Date Cleared
    2024-09-26

    (164 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Product Code :

    GXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthocon Permatage Settable Bone Putty is a self-setting cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects. Permatage Settable Bone Putty should be used only in skeletally mature individuals.
    Device Description
    Permatage Settable Bone Putty is a sterile, biocompatible, nonabsorbable material of putty-like consistency for use in repair of cranial defects. The single use Permatage device contains two separate components of putty-like consistency comprised of granular calcium phosphate, paraffin oil, vitamin E acetate, a triglyceride, and a mixture of nonabsorbable, polyether-based polymers. When mixed together, the components of the Permatage device form a nonabsorbable cohesive, putty-like material that adheres to the bone surface and remains in place following application. The resulting hardening material is primarily calcium phosphate and nonabsorbable polymer materials. Permatage components must be mixed immediately prior to use.
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    K Number
    K232771
    Device Name
    Montage Flowable Settable, Resorbable Bone Paste
    Manufacturer
    Orthocon, Inc.
    Date Cleared
    2024-02-16

    (158 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Product Code :

    GXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthocon Montage Flowable Settable Bone Paste is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous cranial defects with a surface area no larger than 25cm2. Montage Flowable Settable, Resorbable Bone Paste should be used only in skeletally mature individuals.
    Device Description
    Montage Flowable Settable, Resorbable Bone Paste is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The Montage Flowable device comprises two separate components of putty consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the Montage Flowable device form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate. Montage Flowable components must be mixed immediately prior to use.
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    K Number
    K231475
    Device Name
    MONTAGE-QS Settable, Resorbable Bone Putty
    Manufacturer
    Orthocon, Inc.
    Date Cleared
    2023-10-12

    (143 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Product Code :

    GXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthocon MONTAGE-OS Settable Bone Putty is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous cranial defects with a surface area no larger than 25cm². MONTAGE-QS Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.
    Device Description
    MONTAGE-QS Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The MONTAGE-QS device comprises two separate components of putty consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyesterbased polymers. When mixed together, the components of the MONTAGE-QS device form a putty-like material. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE-QS components must be mixed immediately prior to use.
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    K Number
    K221933
    Device Name
    MONTAGE Settable, Resorbable Bone Putty
    Manufacturer
    Orthocon, Inc.
    Date Cleared
    2023-01-13

    (196 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Product Code :

    GXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthocon MONTAGE Settable, Resorbable Bone Putty is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous cranial defects with a surface area no larger than 25cm². MONTAGE Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.
    Device Description
    MONTAGE Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The MONTAGE device comprises two separate components of putty consistency containing granular calcium phosphate, calcium stearate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE device form a putty-like material. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE components must be mixed immediately prior to use.
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    K Number
    K182742
    Device Name
    DB-CMF
    Manufacturer
    Dimensional Bioceramics, LLC
    Date Cleared
    2019-06-20

    (265 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Product Code :

    GXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DB-Cranial is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes or other cranial bone defects and craniotomy cuts with a surface area no larger than 25 cm2. DB-Cranial may be used in the restoration or augmentation of bony contours of the cranial bone skeleton.
    Device Description
    DB-Cranial Bone Void Filler is a moldable and biocompatible calcium phosphate bone void filler. DB-Cranial kit is comprised of two components: a calcium-phosphate powder and a mixing solution in premeasured quantities, which will be mixed together prior to implantation. The 3 cc, 5 cc, and 10 cc DB-Cranial Bone Void Filler kits are provided sterile to SAL of 10-6 and are for single use only. The sterilization method is gamma radiation. Sterilization validation is based on ISO 11137-2:2013 (VDMax25). DB-Cranial Bone Void Filler will be labeled with a shelf life of 30 months.
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    K Number
    K162864
    Device Name
    OsteoVation Impact
    Manufacturer
    Skeletal Kinetics, LLC.
    Date Cleared
    2017-01-13

    (92 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Product Code :

    GXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Osteo Vation Impact is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranialbone defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation Impact may be used in the restoration or augmentation of bony contours of the cranialbone skeleton.
    Device Description
    OsteoVation Impact is a self-setting, calcium phosphate bone void filler designed for single use and biocompatible. Osteo Vation Impact is an impactable (moldable) calcium phosphate. OsteoVation Impact is comprised of two working components: a calcium phosphate, a sodium phosphate (SPMA), carboxymethylcellulose powder, a sodium silicate, sodium phosphate (SPMA) solution, and a mixing system (mixing bowl, pestle and spatula). The two working components are packaged separately and are to be mixed together by the end user prior to implantation. OsteoVation Impact is offered in 3cc, 5cc, and 10cc sterile convenience kits. Each kit includes the two working components in combination with a mixing bowl, pestle, and spatula. It is sterilized using gamma radiation with a minimum dose of 25 kGy and a maximum dose of 50 kGy with a Sterility Assurance Level of 10-9.
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    K Number
    K143661
    Device Name
    DirectInject
    Manufacturer
    STRYKER
    Date Cleared
    2015-09-02

    (253 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Product Code :

    GXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DirectInject is a self-setting, calcium phosphate cement intended to repair neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects not intrinsic to the stability of the bony structure. It is also intended for augmentation or restoration of bony contour in the craniofacial skeleton to include the cranial and zygomatic bones. DirectInject is intended to repair cranial defects with a surface area of 4 cm2 or less. DirectInject is indicated for patients in whom skeletal growth is complete. It can be used in patients with surgically created bone defects.
    Device Description
    Stryker DirectInject consists of a sterile dual paste system, provided pre-filled in a double barrel delivery syringe system, which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is injectable, moldable and biocompatible. The injected cement paste will harden under normal body conditions to form hydroxyapatite, which is the principle mineral constituent of bone. The contents are supplied sterile for single patient use in sizes of 3 cc, 5 cc, and 10 cc.
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    K Number
    K102018
    Device Name
    NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
    Manufacturer
    SYNTHES USA PRODUCTS LLC
    Date Cleared
    2010-09-23

    (66 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Product Code :

    GXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Norian Reinforced and Norian Reinforced Fast Set Putty are indicated for repairing or filling cranial defects and craniotomy cuts with a surface area no larger than 25 cm '. Norian Reinforced and Norian Reinforced Fast Set Putty are also indicated for the restoration or augmentation of bony contours of the cranial skeleton (including frontoorbital areas) such as burr hole voids and other cranial defects.
    Device Description
    Norian Reinforced and Norian Reinforced Fast Set Putty (FSP) are moldable, biocompatible bone cements with added reinforcing fibers. Norian Reinforced and Norian Reinforced FSP are intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton. The material resists cracking during the setting process. When fully cured, the composition formed closely approximates the mineral phase of bone. The product is available in two delivery forms. Norian Reinforced is an injectable paste that is mixed with an automatic mixer, and Norian Reinforced Fast Set Putty is manually mixed with a cup and spatula. Norian Reinforced is provided in a sterile pouch ("Rotary Pouch"). The Rotary Pouch is constructed of a clear-film outer pouch and a foil laminate inner pouch with an attached delivery syringe. The Rotary Pouch contains sterile powderpurpose of adding the mixing solution to the pouch. The mixing solution is contained in the Solution Syringe that is The Rotary Pouch is designed to be placed in an automatic reusable mixer outside the sterile field where the two components are mixed together to form a smooth, viscous paste. The paste remains injectable for approximately 5 minutes at 18°-23°C / 64°-73°F. At body temperature (37°C / 98.6°F), Norian Reinforced begins to harden after 2 minutes and sets in approximately 10 minutes. Norian Reinforced is slowly resorbed over a period of years and replaced with bone during the healing process. Norian Reinforced Fast Set Putty is supplied in two containers. The mixing cup holds sterile powder with fibers and the solution syringe holds sterile solution. When the powder and solution are mixed together with the provided cup and spatula, the resultant putty material can be manipulated for two minutes at 18°-23°C / 64°-73°F. At body temperature (37°C / 98.6°F), Norian Reinforced Fast Set Putty begins to harden after 2 minutes and sets in approximately 3 to 6 minutes. Norian Reinforced Fast Set Putty is slowly resorbed over a period of years and replaced with bone during the healing process.
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    K Number
    K091382
    Device Name
    KRYPTONITE BONE CEMENT
    Manufacturer
    DOCTORS RESEARCH GROUP, INC.
    Date Cleared
    2009-11-16

    (189 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Product Code :

    GXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Kryptonite Bone Cement™ is a resinous material for repairing cranial defects.
    Device Description
    Kryptonite Bone Cement™ is a resinous material to be used as a cranial bone void filler. Kryptonite Bone Cement™ is a self-setting bone cement that is formed by combining and mixing three components, resulting in a mild exothermic polymeric reaction (less than body temperature) that polymerizes into a malleable putty and progresses to a hard cement-like complex. The three components of Kryptonite Bone Cement™ are a liquid pre-polymer isocyanate mixture, a liquid polyester polyol, and a powdered calcium carbonate.
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    K Number
    K070012
    Device Name
    POLYBONE
    Manufacturer
    KYUNGWON MEDICAL CO., LTD.
    Date Cleared
    2007-12-27

    (358 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Product Code :

    GXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PolyBone is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defiect as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
    Device Description
    PolyBone consists of beta-tricalcium phosphate, monocalcium monobasic, calcium sulfate hemihydrate and polyphosphate. PolyBone is indicated for use as cranioplasty cement.
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