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510(k) Data Aggregation

    K Number
    K250622
    Device Name
    Succession™ AFN System
    Date Cleared
    2025-08-07

    (160 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ortho Solutions UK Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K240212
    Device Name
    COGNiTiON™ Staple System
    Date Cleared
    2024-02-23

    (29 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ortho Solutions UK Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ortho Solutions COGNITiON™ Staple System is indicated for hand and foot bone fragments, osteotomy, fixation and joint arthrodesis. The COGNiTiON™ Staple System is not intended for spinal use.
    Device Description
    The COGNITION Staple System is comprised of a set of implantable metallic (Superelastic NiTi Alloy per ASTM F2063) staples and accessory instrumentation. The system consists of a series of two and four-leg staples of various bridge and leg lengths. Each staple is provided to the user in a relaxed state with the staple legs in a converging position. During the staple insertion step, the provided staple driver is used to splay the staple legs, allowing for implantation across the fracture, fusion, or osteotomy site. The staple legs then have the inherent propensity to converge due to the superelastic nature of the NiTi material. This stability is intended to allow for bone healing to occur.
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    K Number
    K210658
    Device Name
    Volition Plating System
    Date Cleared
    2021-04-13

    (40 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ortho Solutions UK Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Volition Plating System is indication and fixation of fractures or osteotomies, revision procedures, joint fusion, and reconstruction of small bones of the feet and ankles, including the toes, talus, and calcaneus; the distal fibula and tibia; as well as the fingers, hands, and wrists. In addition, the non-locking screws and washers are in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
    Device Description
    The Volition Plating System is a set of implantable metallic (Titanium Alloy) bone plates consisting of a series of tubular plates of varying lengths as well as anatomically contoured plates. The Volition Plating System plates are provided with locking and non-locking in Ø2.7mm, Ø3.5mm, & Ø4.0mm previously cleared under K202764. All implants are made from Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136 and are provided non-sterile.
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    K Number
    K202764
    Device Name
    Ortho Solutions Plating System
    Date Cleared
    2020-11-20

    (60 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ortho Solutions UK Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ortho Solutions Plating System is indicated for use in stabilization of fractures or osteotomies, revision procedures, joint fusion, and reconstruction of small bones of the feet and ankles, including the toes, talus, and calcaneus; the distal fibula and tibia; as well as the fingers, hands, and wrists. In addition, the non-locking screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
    Device Description
    The Ortho Solutions Plating System is a set of implantable metallic (Titanium Alloy) bone plates, locking and non-locking screws of various lengths. The system consists of a series of tubular plates of varying lengths as well as anatomically contoured plates. Locking and non-locking screws are provided in Ø2.7mm, Ø3.5mm, & Ø4.0mm in various lengths and are compatible with all plates. All implants are made from Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136 and are provided non-sterile.
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