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510(k) Data Aggregation

    K Number
    K033046
    Device Name
    SUBTALAR PEG IMPLANT
    Manufacturer
    NEXA ORTHOPEDICS, INC.
    Date Cleared
    2003-12-23

    (85 days)

    Product Code
    MJW, PRE, TAB
    Regulation Number
    888.3040
    Why did this record match?
    Product Code :

    MJW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Futura Biomedical Subtalar Peg Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Examples include: Flat foot treatment in children and adolescents Congenital flat foot Unsuccessful long term orthopaedic treatment (shoes, insoles ... ) Tarsal coalitions Painful flat foot Supple deformity in posterior tibial tendon dysfunction Paralytic flat foot Subtalar instability This device is intended to be fixed with bone cement.
    Device Description
    The Futura Biomedical Implant is a one-piece device made of UHMWPE or Cobalt Chromium with titanium plasma spray on the stem, intended to be implanted into the calcaneus of the foot. The implant is designed in 13 sizes and two configurations. The implant which is used in the treatment of excessive motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation.
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