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510(k) Data Aggregation

    K Number
    K991566
    Device Name
    SOLUSTAPLE
    Manufacturer
    NEWDEAL S.A.
    Date Cleared
    1999-08-03

    (90 days)

    Product Code
    JDR,87J
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SOLUSTAPLE

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

    The SOLUSTAPLE® is intended to be implanted for fixation of bone fractures or for bone reconstructions.
    The SOLUSTAPLE® is indicated for:
    ● Akin type osteotomy

    Device Description

    The SOLUSTAPLE® is a staple with two self-drilling tips. The treatment with a Solustaple allow, after possible treatment of the second ray, to recreate a square or Greek foot. Two types of staples are available. In order to safeguard the fonction of the joint, the staple with oblique design will be used.

    AI/ML Overview

    This submission is a 510(k) premarket notification for the SOLUSTAPLE®, a bone fixation staple, and therefore does not contain details about acceptance criteria or specific study results to prove meeting those criteria. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device, not to establish new safety and effectiveness standards through comprehensive clinical trials with pre-defined acceptance criteria.

    The provided documents indicate:

    • Predicate Device: The SOLUSTAPLE® is substantially equivalent to the Depuy, Inc. Varisation Staple.
    • Technological Characteristics Comparison: Both staples are made of stainless steel conforming to ASTM F138 & F139 for bone fixation. This comparison of material properties is the extent of the "proof" provided for the 510(k) submission.

    Therefore, the requested information components related to acceptance criteria, specific study designs, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this type of regulatory submission. The FDA clearance is based on the material equivalence and intended use comparison.

    No study details are provided in this 510(k) submission. The FDA's decision is based on the comparison of technological characteristics to a predicate device already legally marketed.

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