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510(k) Data Aggregation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253705

    Validate with FDA (Live)

    Date Cleared
    2026-03-16

    (112 days)

    Product Code
    Regulation Number
    862.3610
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251888

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-12

    (265 days)

    Product Code
    Regulation Number
    868.5895
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260502

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-12

    (27 days)

    Product Code
    Regulation Number
    876.5130
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252028

    Validate with FDA (Live)

    Date Cleared
    2026-03-11

    (254 days)

    Product Code
    Regulation Number
    N/A
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251818

    Validate with FDA (Live)

    Device Name
    BONTREE PLUS
    Date Cleared
    2026-03-06

    (266 days)

    Product Code
    Regulation Number
    872.3930
    Panel
    Dental
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253920

    Validate with FDA (Live)

    Date Cleared
    2026-03-03

    (85 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253818

    Validate with FDA (Live)

    Date Cleared
    2026-03-03

    (95 days)

    Product Code
    Regulation Number
    892.2080
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K254249

    Validate with FDA (Live)

    Date Cleared
    2026-02-27

    (60 days)

    Product Code
    Regulation Number
    888.3030
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HKT Anatomical Locking Trauma System is intended for adult patients for fixation of fractures, osteotomies, and non-unions of the clavicle, humerus, elbow, radius, ulna, hand, tibia and foot.

    Device Description

    The HKT Anatomical Locking Trauma System is a collection of implantable bone plates and bone screws. The HKT Anatomical Locking Trauma System is intended for adult patients for fixation of fractures, osteotomies, and non-unions of the clavicle, humerus, elbow, radius, ulna, hand, tibia and foot. This system consists of Bone Plates, Bone Screws and Washers

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    K Number
    K253637

    Validate with FDA (Live)

    Date Cleared
    2026-02-18

    (91 days)

    Product Code
    Regulation Number
    888.3565
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    General Total Knee Arthroplasty (TKR) Indications:

    • Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
    • Post-traumatic loss of knee joint configuration and function.
    • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
    • Revision of previous unsuccessful knee replacement or other procedure.
    • Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture-management techniques.
    • Ligamentous instability requiring implant bearing surface geometries with increased constraint.
    • Absent or non-functioning posterior cruciate ligament.

    The subject device is intended for primary or revision total knee arthroplasty.

    Device Description

    The subject device is a sterile, single use device that is intended for use in primary or revision total knee arthroplasty with previously cleared Triathlon® femoral and tibial baseplate components. The subject device adds to the Triathlon® Total Knee System a tibial bearing insert option with an asymmetric articulating surface which is designed to increase medial conformity with the compatible femoral components. The design is intended to provide increased sagittal stability and allow for more natural rotational kinematics. This tibial bearing insert also introduces a material change to the locking wire subcomponent located on the anterior portion of the distal baseplate mating profile. The locking wire component is intended to assemble the insert with a compatible tibial baseplate. The locking wire provided with the Triathlon® X3® Medial Stabilized Tibial Bearing Insert is made from titanium alloy (Ti-6Al-4V).

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