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510(k) Data Aggregation

    K Number
    K243173
    Device Name
    Salto Talaris Ankle PSI System
    Manufacturer
    3D Systems, Inc.
    Date Cleared
    2024-10-25

    (25 days)

    Product Code
    OYK
    Regulation Number
    888.3110
    Why did this record match?
    Product Code :

    OYK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Salto Talaris Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Salto Talaris Ankle PSI System is intended for use with Smith + Nephew's Salto Talaris Total Ankle System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.
    Device Description
    3D Systems' Salto Talaris Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Salto Talaris Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Salto Talaris Total Ankle System instruments, facilitate the positioning of Salto Talaris Total Ankle Prostheses.
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    K Number
    K243174
    Device Name
    Cadence Ankle PSI System
    Manufacturer
    3D Systems, Inc.
    Date Cleared
    2024-10-25

    (25 days)

    Product Code
    OYK
    Regulation Number
    888.3110
    Why did this record match?
    Product Code :

    OYK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cadence Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Cadence Ankle PSI System is intended for use with Smith + Nephew's Cadence Total Ankle System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.
    Device Description
    3D Systems' Cadence Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Cadence Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Cadence Total Ankle System instruments, facilitate the positioning of Cadence Total Ankle Prostheses.
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    K Number
    K241148
    Device Name
    Salto Talaris Ankle PSI System
    Manufacturer
    3D Systems, Inc.
    Date Cleared
    2024-08-30

    (127 days)

    Product Code
    OYK
    Regulation Number
    888.3110
    Why did this record match?
    Product Code :

    OYK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Salto Talaris PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Salto Talaris PSI System is intended for use with Smith + Nephew's Salto Talaris Total Ankle System and its cleared indications for use.
    Device Description
    3D Systems' Salto Talaris Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Salto Talaris Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Salto Talaris Total Ankle System instruments, facilitate the positioning of Salto Talaris Total Ankle Prostheses.
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    K Number
    K241326
    Device Name
    Cadence Ankle PSI System
    Manufacturer
    3D Systems, Inc.
    Date Cleared
    2024-08-30

    (112 days)

    Product Code
    OYK
    Regulation Number
    888.3110
    Why did this record match?
    Product Code :

    OYK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cadence Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Cadence Ankle PSI System is intended for use with Smith + Nephew's Cadence Total Ankle System and its cleared indications for use.
    Device Description
    3D Systems' Cadence Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Cadence Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Cadence Total Ankle System instruments, facilitate the positioning of Cadence Total Ankle Prostheses.
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    K Number
    K231585
    Device Name
    Vantage PSI System
    Manufacturer
    3D Systems, Inc.
    Date Cleared
    2023-06-30

    (30 days)

    Product Code
    OYK
    Regulation Number
    888.3110
    Why did this record match?
    Product Code :

    OYK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vantage PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intra-operatively, and in guiding bone cutting. The Vantage PSI System is intended for use with Exactech's Vantage Total Ankle System and its cleared indications for use.
    Device Description
    3D System's Vantage PSI System is patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides and models are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The surgical guides in combination with Exacted Vantage Total Ankle reusable instruments, facilitate the positioning of Vantage Total Ankle Implants. 3D System s Vantage PSI System produces a variety of patient specific outputs including surgical quides, anatomic models, and case reports.
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    K Number
    K223326
    Device Name
    Axiom PSR System
    Manufacturer
    Restor3d
    Date Cleared
    2023-03-30

    (150 days)

    Product Code
    OYK
    Regulation Number
    888.3110
    Why did this record match?
    Product Code :

    OYK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axiom PSR System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Axiom PSR System is intended for use with the Kinos Axiom Total Ankle System and its cleared indications for use.
    Device Description
    restor3d's Axiom PSR System is an ankle surgical guide system, designed for an individual patient from the patient's CT imaging scans. The subject Axiom PSR System is intended to aid in the placement of Kinos Axiom Total Ankle System (K192778) implant components when used in conjunction with the Kinos Axiom standard, reusable instruments. The Axiom PSR System includes preoperative plans developed with and approved by the operative surgeon, tibia and talus resection guides, manufactured from implant grade titanium, bone models manufactured from biocompatible polymer for use with the Kinos Axiom Total Ankle System.
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    K Number
    K193432
    Device Name
    Vantage PSI System
    Manufacturer
    3D Systems
    Date Cleared
    2020-11-09

    (335 days)

    Product Code
    OYK
    Regulation Number
    888.3110
    Why did this record match?
    Product Code :

    OYK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vantage PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Vantage PSI System is intended for use with Exactech's Vantage Total Ankle System and its cleared indications for use.
    Device Description
    3D System's Vantage PSI System is patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides and models are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The surgical guides in combination with Exactech Vantage Total Ankle reusable instruments, facilitate the positioning of Vantage Total Ankle Implants. 3D System's Vantage PSI System produces a variety of patient specific outputs including surgical guides, anatomic models, and case reports for use with Exactech's Vantage Total Ankle System (K152217 and K183343).
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