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510(k) Data Aggregation

    K Number
    K232998
    Device Name
    Montage- XT Settable, Resorbable Hemostatic Bone Putty
    Manufacturer
    Orthocon, Inc.
    Date Cleared
    2023-10-12

    (20 days)

    Product Code
    MTJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MTJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Montage-XT Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries. Montage-XT is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
    Device Description
    MONTAGE-XT Settable. Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use MONTAGE-XT device contains two separate components of putty-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE-XT device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting hardening material is primarily comprised of calcium phosphate. MONTAGE-XT must be mixed immediately prior to use. When applied to surgically cut or traumatically broken bone, MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
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    K Number
    K213418
    Device Name
    MONTAGE Settable, Resorbable Hemostatic Bone Putty
    Manufacturer
    Orthocon, Inc.
    Date Cleared
    2023-08-30

    (679 days)

    Product Code
    MTJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MTJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MONTAGE Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries. MONTAGE is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
    Device Description
    MONTAGE Settable. Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The MONTAGE device comprises two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, 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 cohesive putty-like material that adheres to the bleeding bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE components must be mixed immediately prior to use. When applied to surgically cut or traumatically broken bone, MONTAGE Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
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    K Number
    K231386
    Device Name
    Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
    Manufacturer
    Orthocon, Inc.
    Date Cleared
    2023-07-11

    (60 days)

    Product Code
    MTJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MTJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
    Device Description
    Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The single use device contains two separate components of paste-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols, a mixture of a lactide-diester and polyester-based polymers and barium sulfate. When mixed together, the components of the device form a resorbable paste-like material that can be applied directly to bleeding bone by means of a single-use applicator (delivery device). The resulting hardening paste is primarily comprised of calcium phosphate. Montage Flowable XRO is mixed immediately prior to use. When applied to surgically cut or traumatically broken bone. Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste achieves local control of bleeding by acting as a mechanical barrier (tamponade).
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    K Number
    K200452
    Device Name
    Meril-Bonewax
    Manufacturer
    M/s. Meril Endo Surgery Private Limited
    Date Cleared
    2023-03-27

    (1127 days)

    Product Code
    MTJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MTJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MERIL - BONEWAX™ is intended to be used in the control of bleeding from bone surfaces during surgical operations.
    Device Description
    MERIL - BONE WAX™ is ivory white, intended to aid mechanically in the control of bleeding of bone injuries, whether attributable to trauma or surgical intervention. It is composed of refined beeswax with Iso propyl myristate added as softening agent, and is supplied sterile in thin sheets. It is opaque and has a waxy odor. It is available as 2 or 2.5gm bone wax per pack. MERIL - BONE WAX™ achieves local hemostasis of bone by acting as a mechanical (tamponade) barrier. It does not act biochemically and is nonabsorbable.
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    K Number
    K220315
    Device Name
    MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
    Manufacturer
    Orthocon, Inc.
    Date Cleared
    2022-03-11

    (36 days)

    Product Code
    MTJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MTJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
    Device Description
    MONTAGE-XT Settable. Resorbable Hemostatic Bone Putty is a sterile. biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use MONTAGE-XT device contains two separate components of putty-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE-XT device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting hardening material is primarily comprised of calcium phosphate. MONTAGE-XT must be mixed immediately prior to use. When applied to surgically cut or traumatically broken bone. MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
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    K Number
    K202363
    Device Name
    HBP7 Settable Hemostatic Bone Putty
    Manufacturer
    Orthocon, Inc.
    Date Cleared
    2021-01-19

    (153 days)

    Product Code
    MTJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MTJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HBP7 Settable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
    Device Description
    HBP7 Settable Hemostatic Bone Putty is a sterile, biocompatible, nonabsorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use HBP7 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, polyetherbased polymers. When mixed together, the components of the HBP7 device form a nonabsorbable putty-like material that can be applied directly to bleeding bone. The resulting material is primarily comprised of calcium phosphate. HBP7 must be mixed immediately prior to use. When applied to surgically cut or traumatically broken bone. HBP7 Settable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
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    K Number
    K193052
    Device Name
    HBP6 Settable, Resorbable Hemostatic Bone Paste
    Manufacturer
    Orthocon, Inc.
    Date Cleared
    2020-03-27

    (147 days)

    Product Code
    MTJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MTJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HBP6 Settable, Resorbable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
    Device Description
    The HBP6 Settable, Resorbable Hemostatic Bone Paste is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The single use HBP6 device contains two separate components of paste-like consistency comprised of 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 HBP6 device form a resorbable paste-like material that can be applied directly to bleeding bone by means of a single-use applicator (delivery device). The resulting hardening paste is primarily comprised of calcium phosphate. HBP6 is mixed immediately prior to use. When applied to surgically cut or traumatically broken bone, HBP6 Settable, Resorbable Hemostatic Bone Paste achieves local control of bleeding by acting as a mechanical barrier (tamponade).
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    K Number
    K191140
    Device Name
    MONTAGE-QS Settable, Resorbable Hemostatic Bone
    Manufacturer
    Orthocon, Inc.
    Date Cleared
    2019-07-18

    (79 days)

    Product Code
    MTJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MTJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
    Device Description
    MONTAGE-QS Settable. Resorbable Hemostatic Bone Putty is a sterile. biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use MONTAGE-QS device contains two separate components of putty-like consistency comprised of 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-QS device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting material is primarily comprised of calcium phosphate. MONTAGE-QS must be mixed immediately prior to use. When applied to surgically cut or traumatically broken bone. MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
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    K Number
    K153317
    Device Name
    HEMASORBPLUS Resorbable Hemostatic Bone Putty
    Manufacturer
    ORTHOCON, INC.
    Date Cleared
    2016-11-30

    (378 days)

    Product Code
    MTJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MTJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthocon HemasorbPlus Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
    Device Description
    HEMASORBPLUS™ Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The material contains a mixture of alkylene oxide polymer based materials, vitamin E acetate, granular calcium phosphate and sodium carboxymethylcellulose. HEMASORBPLUS™ Resorbable Hemostatic Bone Putty is virtually odorless, off-white in color and can be spread easily onto bone with minimal adhesion to surgical gloves. The putty requires no kneading or warming prior to application. When applied to surgically cut or traumatically broken bone, HEMASORBPLUS™ Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). HEMASORBPLUS Resorbable Hemostatic Bone Putty has been shown to be mixable with autograft in a 1:1 volume ratio.
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    K Number
    K153095
    Device Name
    ROP Resorbable Hemostasis Material
    Manufacturer
    Resorbable Orthopedic Products, LLC
    Date Cleared
    2016-02-17

    (114 days)

    Product Code
    MTJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    MTJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ROP Bone Hemostasis Material is a water-soluble material indicated for use to control bleeding from bone surfaces.
    Device Description
    The ROP Bone Hemostasis Material is a blend of water-soluble alkylene oxide copolymers. It contains no additives or colorants. The product is provided in a stick-like form, contained in a capped delivery tube. Each tube contains approximately 6.0 grams of the material. It is to be extruded from the container by rotation of the base of the tube for application to bleeding bone defect. The ROP Bone Hemostasis Material is, as the predicate, a water soluble wax-like substance and is slippery when wet. The delivery tube is a barrier between the surgeon's wet gloved hand and the material, permitting application to the boney defect in the manner similar to handling a crayon. ROP Bone Hemostasis Material is sterilized by a validated gamma irradiation process. It is labeled for single surgical use and is not to be resterilized. The tube is provided in a secondary wrap to permit delivery into a sterile field. The device is a resorbable material in contact with bone tissue for less than 30 days.
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