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510(k) Data Aggregation

    K Number
    K120029
    Device Name
    HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET
    Manufacturer
    SOLANA SURGICAL LLC
    Date Cleared
    2012-02-06

    (33 days)

    Product Code
    KWD
    Regulation Number
    888.3730
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K023684,K023770
    Why did this record match?
    Reference Devices :

    K023684, K023770

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

    The Solana Surgical LLC, Hemi Phalangeal Implant System is intended for use as a hemi-arthroplasty implant for the metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint.

    The device is intended for single use to be used with bone cement or press fit without bone cement.

    Device Description

    The Solana Surgical Implant is a one-piece device made of Cobalt Chromium (with titanium plasma spray coated stem) intended to replace the articulating surface of the phalangeal bone at the metatarsalphalangeal (MTP) joint. The implant is available in a range of sizes (3) to match the geometry of the metatarsal phalangeal joint. Design features include an articulating surface and a stem which extends distally in the intramedullary canal of the proximal phalanx. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the development of this implant.

    AI/ML Overview

    The provided text describes a medical device, the Solana Surgical Hemi Phalangeal Implant System, and its substantial equivalence to predicate devices, but it does not contain any information regarding acceptance criteria, device performance, or a study proving it meets acceptance criteria.

    The document is a 510(k) summary and an FDA clearance letter, which focuses on establishing substantial equivalence based on similarities in:

    • Intended use: Hemi-arthroplasty implant for the metatarsophalangeal joint to treat degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and unstable/painful MTP joint.
    • Device description: One-piece device made of Cobalt Chromium (with titanium plasma spray coated stem).
    • Materials: Industry standard materials, no new materials.
    • Design features: Articulating surface and a stem extending distally into the intramedullary canal.
    • Sizes: Available in a range of 3 sizes.
    • Usage: Single use, with or without bone cement.

    Therefore, I cannot provide the requested table or details about a study demonstrating acceptance criteria, as this information is not present in the provided text. The document is about regulatory clearance for a medical implant, not a performance study of an AI/software device.

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