LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K981194
    Device Name
    FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT
    Manufacturer
    NEXA ORTHOPEDICS, INC.
    Date Cleared
    1998-06-30

    (89 days)

    Product Code
    KWH
    Regulation Number
    888.3720
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K780132
    Why did this record match?
    Device Name :

    FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Indications for use of this implant are:

    • Hallux limitus or hallux rigidus. .
    • Painful rheumatoid arthritis. .
    • . Hallux abducto valgus associated with arthritis.
    • Unstable or painful joint from previous surgery. .
    Device Description

    The Flexible Great Toe implant is a double-stemmed silicone prosthesis to supplement first metatarsophalangeal joint arthroplasty. The implant is designed to act as a dynamic joint spacer between the head of the 1st metatarsal and base of the proximal phalanx. A grommet option is offered for surgeons who choose to utilize grommets in their surgical procedure. This is consistent with the description and intended use of the Swanson Flexible Hinge Toe Implant.

    AI/ML Overview

    This submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a 510(k) summary for a flexible great toe implant, focusing on substantial equivalence to a predicate device and its intended use. The document discusses:

    • Device Description and Intended Use: A double-stemmed silicone prosthesis for first metatarsophalangeal joint arthroplasty, acting as a dynamic joint spacer.
    • Indications for Use: Hallux limitus/rigidus, painful rheumatoid arthritis, hallux abducto valgus with arthritis, unstable/painful joint from previous surgery.
    • Technological Characteristics: Double-stemmed, silicone, hinged midsection, titanium press fit grommets, angled hinge block, and tapered stems designed based on resected bone geometry.
    • Predicate Device: Swanson Flexible Hinge Toe Implant by Dow Corning (K780132).
    • Performance Standards: None specifically for great toe silicone joint implants at the time, but materials for grommets comply with ASTM F 67.

    The document states, "There are currently no performance standards for great toe silicone joint implants." This indicates that formal acceptance criteria based on performance standards are not applicable or were not established in this submission.

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because such details are not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1