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510(k) Data Aggregation

    K Number
    K120924
    Device Name
    BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG
    Manufacturer
    CORENTEC CO., LTD
    Date Cleared
    2012-09-10

    (167 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K103431,K000306
    Predicate For
    K150007,K162127,K172806,K182221,K210614,K220468,K223223
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Bencox Mirabo Cup System is intended for use in total hip arthroplasty in primary or revision surgery for the following conditions:

    a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis

    b. Inflammatory degenerative joint disease, such as rheumatoid arthritis

    c. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

    d. Patients with failed previous surgery where pain, deformity, or dysfunction persists

    e. Revision of previously failed total hip arthroplasty

    Device Description

    The Bencox Mirabo Cup System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, a porous coated non hemispherical outer shell manufactured from titanium alloy (Ti-6AI-4V) and a liner manufactured from highly crosslinked ultra high molecular weight polyethylene (UHMWPE), which locks into the outer shell. The liner component articulates with a femoral head of an appropriate diameter.

    The Acetabular system consists of Bencox Mirabo Cup, Bencox Mirabo PE Inserts (Standard & Elevated), Bencox Bone Screw, Dome hole & Screw Hole Plugs; and Bencox THR Instrumentation. The components are manufactured from the following materials: Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401); and ultra-high molecular weight polyethylene conforming to ASTM F648, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants. The acetabular cup is sterilized by gamma irradiation and acetabular liner is sterilized by ethylene oxide, same as its predicate device cleared under K103431.

    AI/ML Overview

    This 510(k) pertains to a medical device (acetabular cup system) and not a diagnostic AI/ML device, therefore, the requested information regarding AI/ML device performance and testing is not applicable. The provided document concerns a Special 510(k) for device modification, focusing on mechanical performance and substantial equivalence to predicate devices. The criteria and studies described relate to the physical properties and wear characteristics of the Bencox Mirabo Cup System, not to a diagnostic or AI-driven system.

    However, I can provide the available information related to the performance data as described in the document for this device.

    Acceptance Criteria and Device Performance (Mechanical Testing)

    The document states that "Performance testing was carried out to demonstrate substantial equivalence and included methods described in the following standards: ISO 14242, ASTM F1820 and ASTM F2582."

    The reported device performance is summarized as: "The acetabular cup system performed either similar or better than the predicate devices."

    Acceptance Criteria (Standards Used for Testing)Reported Device Performance
    ISO 14242 (likely refers to ISO 14242-1 or -2, related to wear of total hip-joint prostheses)Performed similar to or better than predicate devices
    ASTM F1820 (Standard Test Method for Determining the Latching Strength of Acetabular Shells with Locking Devices)Performed similar to or better than predicate devices
    ASTM F2582 (Standard Test Method for Measuring the Impingement of Modular Acetabular Total Hip Prostheses)Performed similar to or better than predicate devices
    Other Mechanical Testing (Wear, Liner Torsion & Lever Out, Push Out)Performed similar to or better than predicate devices

    Information Not Applicable to this Device (as it is not an AI/ML diagnostic/analytic device):

    • Sample size used for the test set and the data provenance
    • Number of experts used to establish the ground truth
    • Qualifications of those experts
    • Adjudication method
    • Multi-reader multi-case (MRMC) comparative effectiveness study
    • Standalone (algorithm only) performance
    • Type of ground truth used
    • Sample size for the training set
    • How the ground truth for the training set was established

    Additional Information from the Document:

    • Test Type: Mechanical testing
    • Purpose of Tests: To demonstrate substantial equivalence to predicate devices.
    • Comparison: The subject device was compared to the predicate devices.
    • Conclusion: "Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy."
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