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510(k) Data Aggregation

    K Number
    K200951
    Device Name
    Accu-Joint Hemi Implant
    Manufacturer
    Accufix Surgical, Inc.
    Date Cleared
    2020-12-08

    (243 days)

    Product Code
    KWD
    Regulation Number
    888.3730
    Why did this record match?
    Applicant Name (Manufacturer) :

    Accufix Surgical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accu-Joint Hemi Implant, a hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock, along with the following clinical conditions: Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint. The Accu-Joint Hemi Implant is intended to be used with bone cement. The metatarsal head and phalangeal base may not be used together at the same joint.
    Device Description
    The Accu-Joint Hemi Implant consists of a hemi-arthroplasty metatarsal head or phalangeal base intended to resurface the metatarsophalangeal joint. These components are used for hemiarthroplasty and are not used together to create a joint Hemi Implant is designed with a threaded shaft for intramedullary insertion. The implant has a driver pocket on the articular surface axially aligned with the threaded shaft. To accommodate a wide range of patient anatomies, various sizes are offered.
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