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510(k) Data Aggregation

    K Number
    K171690
    Device Name
    Trident Extremity Fixation System
    Date Cleared
    2018-05-08

    (335 days)

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

    Trident Orthopedics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Trident Extremity Fixation System consisting of plates and screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bone of the feet, hand, ankle and toes. Specific examples include: - Arthrodesis of the first metatarsalcuneiform joint (Lapidus fusion procedure) - Arthrodesis of the first metatarsalphalangeal joint (MTP fusion procedure) - Primary and revision MTP fusion due to hallux rigidus and/or hallux valgus corrections - Revision of failed first MTP arthroplasty implant 2nd, 3rd and 4th metatarsal weil osteotomy correction indications - Metatarsal osteotomies to correct hallux valgus bunion indications - Fractures of the fifth metatarsal bone in the foot - Carpal bone fusions and fractures Flatfoot Osteotomies: - Lateral column lengthening (Evans osteotomy) - Plantar flexion opening wedge osteotomy of the medial cuneiform (Cotton osteotomy) - Medial displacement calcaneal osteotomy Midfoot/Hindfoot Arthrodesis/Fusions - Lisfranc arthrodesis and/or stabilization - 1st, 2nd, 3rd and 4th Tarsometatarsal (TMT) fusions - Navicular-Cuneiform (NC) joint fusions - Talo-Navicular (TN) joint fusions - Calcaneo-Cuboid (CC) joint fusions - Medial column fusions (NC and 1st TMT) The Trident Extremity Fixation System screws and plates are indicated for use with the Trident Plates and Screws of the same material. The locking and non-locking solid cortical screws, cannulated screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device.
    Device Description
    The Subject device is manufactured from titanium conforming to ASTM F-136. The system includes plates in various sizes as well as locking and non-locking screws to be used with the plates. The bones screws are available in diameter sizes from 3.0 mm to 7.3 mm diameter and lengths from 10 mm to 100 mm. The system also includes reusable instrumentation for delivery of the implantable components. The Subject device has a similar range of sizes as its predicate.
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