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510(k) Data Aggregation

    K Number
    K251050

    Validate with FDA (Live)

    Date Cleared
    2025-12-19

    (260 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252191

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-17

    (156 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K250988

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-11

    (255 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K252997

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-11

    (84 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252661

    Validate with FDA (Live)

    Date Cleared
    2025-11-19

    (89 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SternaFuse Ti Fixation System is indicated for use in the stabilization and fixation of fractures of the anterior chest wall or sternum, including sternal fixation following sternotomy, sternal fractures, and sternal reconstructive surgical procedures to promote fusion. The system is intended for use in patients with normal and/or poor bone quality. The device is for prescription use only.

    Device Description

    The SternaFuse Ti Fixation System implants are manufactured from titanium alloy (Ti6AL-4V ELI) Per ASTM F136 implant quality titanium plates, and screws intended to stabilize and fixate fractures of the anterior chest wall. The components include various sizes to facilitate customization according to the requirements of the anterior chest wall repair. Self-drilling locking screws come in 3.5mm diameter, and lengths of 10mm, 12mm,14mm,16mm,18mm and 20mm. Multiple plates may be used in one anterior chest wall repair.

    All implants are provided non-sterile. The implants should never be reused under any circumstance.

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    K Number
    K253423

    Validate with FDA (Live)

    Date Cleared
    2025-11-18

    (54 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ToeJack MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders, such as hallux valgus.

    Device Description

    The ToeJack MIS Bunion System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and locking 3.0mm diameter titanium screws that provide fixation for the first metatarsal in the correction of a bunion. Specifically, the plate has 4 screw-receiving holes. It is designed to allow for intramedullary insertion of the proximal shaft with 2 screw fixation and extramedullary medial insertion of the 2 distal screws. Further, the device is provided with a screw targeting insertion guide.

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    K Number
    K250865

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-11-14

    (238 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KLS Martin IPS Forearm System is indicated for use in forearm fractures, osteotomies, and arthrodeses. It is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or will not be crossed by fixation.

    Device Description

    The KLS Martin Individual Patient Solutions (IPS) Forearm System is comprised of additively manufactured, patient-specific models, guides and metallic bone plates. The plates will be used in conjunction with previously cleared metallic bone screws and locking pins for internal fixation, alignment, stabilization, reconstruction, and/or corrective osteotomies of the radius and/or ulna. The devices are designed and manufactured to be patient-specific based on the electronic medical image of the patient's anatomy; with input from the physician during virtual planning, prior to finalization, and prior to production of the device. The physician provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure its dimensional properties allow an appropriate fit.

    Implants are provided non-sterile and are manufactured using additive methods from Ti-6Al-4V. The system also includes the necessary fixation devices and instruments to facilitate placement of the implants.

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    K Number
    K252949

    Validate with FDA (Live)

    Date Cleared
    2025-11-13

    (58 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Skeletal Dynamics Geminus Volar Distal Radius Plating System is intended for fixation of fractures and osteotomies of the distal radius.

    Device Description

    The current Geminus Volar Distal Radius Plating System includes medical grade titanium alloy (Ti 6Al-V4 ELI) bone plates offered in 12 sizes, an ulnar hook plate, Cobalt-Chromium-Molybdenum (CoCrMo) and titanium alloy (Ti 6Al-V4 ELI) bone screws and pegs, and specialized instrumentation for the repair of distal radius and osteotomies. The system also includes the Radial Hook Plate extensions to buttress a volar marginal fragment, and the Buttress Button assembly to capture and hold small dorsal corner fractures.

    The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.

    The Geminus Volar Distal Radius Plating System is comprised of:

    System ComponentsMaterial(s)Standard(s)
    Geminus Volar Distal Radius PlatesTi 6Al-V4 ELIASTM F136
    Locking Smooth PegsLocking Threaded PegsHigh Compression Locking PegsNon-Locking Threaded PegsCortical Non-Locking ScrewsCortical Locking ScrewsTi 6Al-V4 ELIASTM F136
    Washer ButtonTi 6Al-V4 ELIASTM F136
    Polyaxial Locking ScrewsCoCrMoASTM F1537
    Geminus Hook Plate ScrewsTi 6Al-V4 ELIASTM F136
    Geminus Ulnar Hook PlateTi 6Al-V4 ELIASTM F136
    Geminus Radial Hook PlateTi 6Al-V4 ELIASTM F136
    Geminus Buttress Button AssemblyTi 6Al-V4 ELICP Ti Grade 2ASTM F136ASTM F86
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    K Number
    K252959

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-11-12

    (57 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Wristar MultiAx Distal Radius Kit is indicated for:

    • Fixation of complex intra- and extra-articular fractures of the distal radius
    • osteotomies of the distal radius
    Device Description

    The WRISTAR MultiAx Distal Radius Sterile Kit is indicated for both intra-articular and extra-articular fractures of the distal radius (2R3-A2 and 2R3-A3, 2R3-B/C) and for distal radius osteotomies. The system is comprised of various plates and screws which allow it to be customized to a patient's anatomy and fracture pattern. The plate is secured in place via MultiAxial and cortical screws.

    The WRISTAR MultiAx Distal Radius Volar Plate is available in various lengths to accommodate patient anatomy and fracture type of the malleolus bone. The plate is provided either with threaded holes or tapered holes. The head of the plate has a shape and contour that provides bone support and a low profile that minimizes the potential for soft tissue irritation.

    Screws are available in two designs: cortical and MultiAx.

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