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510(k) Data Aggregation

    K Number
    K240461
    Device Name
    OsteoSinter® EVANS and COTTON wedges and related accessories
    Manufacturer
    Ames Medical Prosthetic Solutions, S.A.U.
    Date Cleared
    2024-12-06

    (294 days)

    Product Code
    PLF, HRS
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    PLF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OsteoSinter® EVANS and COTTON wedges are intended to be used for internal bone fixation of bone fractures, fusions, or osteotomies in the foot. Specific Indications include: - Opening wedge osteotomies of the foot (including osteotomies for Hallux Valgus). - Opening wedge of Medial Cuneiform or Cotton osteotomies. - Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy). - Metatarsal/Cuneiform arthrodesis. OsteoSinter® EVANS and COTTON wedges are indicated for use with ancillary bone fixation. OsteoSinter® EVANS and COTTON wedges are not indicated for use in the spine
    Device Description
    The OsteoSinter® EVANS and COTTON wedges are sterile, single use porous titanium implantable wedges, available in varied footprints and heights, intended to be used for correction of foot deformities.
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    K Number
    K243231
    Device Name
    Trigon PEEK HA Wedges
    Manufacturer
    Nvision Biomedical Technologies
    Date Cleared
    2024-11-08

    (30 days)

    Product Code
    PLF, HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    PLF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: - · Cotton (opening wedge) Osteotomies of the Medial Cuneiform - · Evans Lengthening Osteotomies - · Subtalar Arthrodesis - · First Metatarsal-Cuneiform Lengthening Arthrodesis - · Calcaneocuboid Arthrodesis - · Calcaneal Z Lengthening Osteotomies - · MTP Lengthening Arthrodesis - · Lesser Metatarsal-Cuneiform Lengthening Arthrodesis - · Navicular-Cuneiform Arthrodesis - · Talonavicular Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
    Device Description
    The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate an inserter-receiving hole and/or two screw-receiving holes and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular, oval, and teardrop shaped footprints in a range of sizes and in multiple thicknesses. The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm. When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. Lapidus, Calcaneocuboid, MTP, Lesser Metatarsal, and Midfoot Wedges require additional fixation not provided in the Trigon System. When used without the provided screws, Trigon wedges are intended for use with ancillary fixation.
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    K Number
    K234116
    Device Name
    Trigon Trigon HA Stand-Alone Wedge Fixation System
    Manufacturer
    Nvision Biomedical Technologies
    Date Cleared
    2024-01-26

    (30 days)

    Product Code
    PLF, HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    PLF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: - · Cotton (opening wedge) Osteotomies of the Medial Cuneiform - · Evans Lengthening Osteotomies - · Subtalar Fusion - · First Metatarsal-Cuneiform Lengthening Arthrodesis - · Calcaneocuboid Arthrodesis - · Z-Calcaneal Lengthening Osteotomies - · MTP Lengthening Arthrodesis The Trigon HA Stand-Alone Wedge Fixation System is intended for use with ancillary fixation and is not intended for use in the spine.
    Device Description
    The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular, oval, and teardrop shaped footprints in a range of sizes and in multiple thicknesses. The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm. When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. Lapidus, Calcaneocuboid, and MTP Wedges require additional fixation not provided in the Trigon System. When used without the provided screws, Trigon wedges are intended for use with ancillary fixation.
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    K Number
    K231496
    Device Name
    TITAN 3-D Wedge System
    Manufacturer
    Paragon 28 Inc
    Date Cleared
    2023-08-22

    (90 days)

    Product Code
    PLF
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    PLF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TITAN 3-D® Wedge System implants are indicated to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the foot and ankle. The TITAN 3-D® Wedge System implants are intended for use with ancillary fixation. The TITAN 3-D® Wedge System implants are not indicated for use in the spine.
    Device Description
    The TITAN 3-D® Wedge System contains a series of titanium alloy implants used for the correction of small bones in the foot. It is offered in varying shapes and sizes to accommodate a variety of small bone applications. The implants are sold sterile.
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    K Number
    K223226
    Device Name
    Trigon™ HA Stand-Alone Wedge Fixation System
    Manufacturer
    Nvision Biomedical Technologies, Inc.
    Date Cleared
    2022-12-01

    (44 days)

    Product Code
    PLF, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    PLF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: - · Cotton (opening wedge) Osteotomies of the Medial Cuneiform - · Evans Lengthening Osteotomies - · Subtalar Fusion - · First Metatarsal-Cuneiform Lengthening Arthrodesis - Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
    Device Description
    The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular oval and teardrop shaped footprints in a range of sizes and in multiple thicknesses. The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm. When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating, except for the Lapidus and Calcaneocuboid Wedges which will require ancillary fixation not provided in the Trigon System. When used without the provided screws, Trigon wedges are intended for use with ancillary fixation.
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    K Number
    K220197
    Device Name
    Trigon HA Wedge Fixation System
    Manufacturer
    Nvision Biomedical Technologies, Inc
    Date Cleared
    2022-02-23

    (30 days)

    Product Code
    PLF, HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    PLF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: - Cotton (opening wedge) Osteotomies of the Medial Cuneiform - Evans Lengthening Ssteotomies - Subtalar Fusion - First Metatarsal-Cuneiform Lengthening Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
    Device Description
    The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular and oval shaped footprints in a range of sizes and in multiple thicknesses. The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm. When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating, except for the Lapidus Wedges which will require ancillary fixation not provided in the Trigon System. When used without the provided screws, Trigon wedges are intended for use with ancillary fixation.
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    K Number
    K201314
    Device Name
    Restor3d Utility Wedge
    Manufacturer
    restor3d, Inc.
    Date Cleared
    2021-06-17

    (395 days)

    Product Code
    PLF, HRS
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    PLF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The restor3d Utility Wedges are intended to be used for internal bone fractures or osteotomies in the ankle and foot, such as: - · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus - · Opening wedge of Medial Cuneiform or Cotton osteotomies - · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) - · Metatarsal Cuneiform osteotomies - · Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies (TMT or Lapidus) - · Hindfoot osteotomies such as Ankle fusion and Subtalar fusion The restor3d Utility Wedges are intended for use with supplemental fixation. The restor 3d Utility Wedges are not intended for use in the spine.
    Device Description
    The proposed Utility Wedge is a sterile, single use medical grade titanium alloy (Ti-6Al-4V) device, available in varied footprints and heights, designed for opening and lengthening osteotomy procedures of the foot, including Lapidus and Subtalar.
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    K Number
    K203445
    Device Name
    Trigon HA Stand-Alone Wedge Fixation System
    Manufacturer
    Nvision Biomedical Technologies, Inc.
    Date Cleared
    2020-12-21

    (28 days)

    Product Code
    PLF, HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    PLF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trigon™ HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: - Cotton (opening wedge) osteotomies of the medial cuneiform - . Evans lengthening osteotomies The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
    Device Description
    The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular and kidney shaped footprints in a range of sizes (16x16mm to 20x22mm) and in multiple thicknesses (5 to 12mm). The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm. When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. When used without the provided screws Trigon wedges are intended for use with ancillary fixation.
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    K Number
    K193414
    Device Name
    Trigon HA Stand-Alone Wedge Fixation System
    Manufacturer
    Nvision Biomedical Technologies, Inc
    Date Cleared
    2020-02-25

    (78 days)

    Product Code
    PLF, HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    PLF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trigon™ HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as: - Cotton (opening wedge) osteotomies of the medial cuneiform - Evans lengthening osteotomies The Trigon Ti wedges are intended for use with ancillary fixation. The Trigon Ti Stand-Alone Wedge Fixation System is not intended for use in the spine.
    Device Description
    The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular and kidney shaped footprints in a range of sizes (16x16mm to 20x22mm) and in multiple thicknesses (5 to 12mm). The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm. When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. When used without the provided screws Trigon wedges are intended for use with ancillary fixation.
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    K Number
    K192645
    Device Name
    Trigon™ Ti Stand-Alone Wedge Fixation System
    Manufacturer
    Nvision Biomedical Technologies, Inc.
    Date Cleared
    2019-12-23

    (90 days)

    Product Code
    PLF, HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Product Code :

    PLF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trigon™ Ti Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as: - Cotton (opening wedge) osteotomies of the medial cuneiform - Evans lengthening osteotomies The Trigon Ti wedges are intended for use with ancillary fixation. The Trigon Ti Stand-Alone Wedge Fixation System is not intended for use in the spine.
    Device Description
    The Trigon Ti Stand-Alone Wedge Fixation System is a family of additively manufactured titanium wedges used for angular correction of small bones of the foot. The wedges incorporate an organized lattice structure and two screw-receiving holes. The system rectangular and kidney shaped wedges may or may not include a window for containing grafting material. The wedges are designed in rectangular and kidney shaped footprints in a range of sizes (16x16mm to 20x22mm) and in multiple thicknesses (5 to 12mm). The associated 2.5mm diameter screws are designed in lengths of 10 to 20mm. When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. When used without the provided screws Trigon wedges are intended for use with ancillary fixation. Windowless wedge designs that do not allow for graft placement should only be used with ancillary plating.
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