LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K220468
    Device Name
    BENCOX Mirabo Cup System
    Manufacturer
    Corentec Co.,Ltd.
    Date Cleared
    2022-05-18

    (90 days)

    Product Code
    LPH,LZO
    Regulation Number
    888.3358
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K120924,K150007,K162127,K172806,K182221,K190904,K091508
    Predicate For
    K223223
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BENCOX Mirabo Cup System of Bencox Total Hip System is intended for Cementless use in partial or 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 trochantric 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 a Cementless hip acetabular system (Poly Liner) intended to be used with femoral components including either metal or ceramic heads and femoral stems to form a total hip system for hip arthroplasty. This submission consists of the following line extension components:

    • Acetabular Cup Bencox Mirabo Cup
    • . Acetabular Liner - Bencox Mirabo PE Liner

    Acetabular Cup: Bencox Mirabo Cup

    The Bencox Mirabo Cup Spec. Inclusion is similar to Bencox Mirabo Cup cleared under K162127 & K120924 with respect to material - Titanium alloy (ASTM F136), coating with pure Titanium powder (ASTM F1580), design, locking system, manufacturing, packaging and sterilization. This submission is only for the inclusion of specification of acetabular cups with external diameter 50 mm.

    Acetabular Liner: Bencox Mirabo PE Liner

    The Bencox Mirabo PE Liner specification inclusion is similar to Bencox Mirabo PE Liner cleared under K162127 & K150007, with respect to material, conforming to ASTM F648, Type 2 (GUR 1050), and irradiated with average dose of 10.0 Mrad of gamma radiation, design, locking system, manufacturing, packaging and sterilization. This submission is only for the inclusion of specification of Liner with head size, 28/42, 32/42, 36/42 mm.

    AI/ML Overview

    This FDA 510(k) submission for the BENCOX Mirabo Cup System is for a medical device (hip joint prosthesis components), not an AI/ML software. Therefore, the information typically requested regarding acceptance criteria and studies for AI/ML performance (such as test set sample sizes, data provenance, expert ground truth, MRMC studies, or training set details) is not applicable to this document.

    The document discusses mechanical testing and biocompatibility studies, which are relevant to the safety and effectiveness of a physical medical implant. Here's a summary of the non-clinical testing referenced for this device, which serves as the "study that proves the device meets the acceptance criteria" for a physical implant:

    Acceptance Criteria and Reported Device Performance (Non-Clinical Testing for Physical Device)

    Acceptance Criteria (Test Standard / Requirement Implied)Reported Device Performance (Compliance)
    Wear Testing (as per ISO 14242-1)Referenced (implies compliance)
    Liner Torsion (as per ASTM F1820)Referenced (implies compliance)
    Pull out Testing (as per ASTM F1820)Referenced (implies compliance)
    Push out Testing (as per ASTM F1820)Referenced (implies compliance)
    Impingement (as per ASTM F2582)Referenced (implies compliance)
    Cup deformation (as per ISO 7206-12)Referenced (implies compliance)
    Acetabular cup fatigue (as per ASTM F3090-20)Referenced (implies compliance)
    Range of Motion (as per ISO21535)Referenced (implies compliance)
    BiocompatibilityReferenced (implies compliance)
    Pyrogen testing (in accordance with USP<161>, USP<85>, and ANSI/AAMI ST72)Meets recommended limits per FDA's Guidance Document "Submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile."
    Bacterial endotoxin testing (BET) (as specified in ANSI/AAMI ST72:2011)Achieves an Endotoxin limit of < 20EU/Device.

    Information Not Applicable or Available in the Provided Document (as it pertains to AI/ML devices):

    The following points are not applicable to this 510(k) submission because it concerns a physical orthopaedic implant, not an AI/ML software device. Information relevant to AI/ML performance would not be found in this type of submission.

    • Sample sizes used for the test set and data provenance
    • Number of experts used to establish ground truth
    • Qualifications of experts
    • Adjudication method for the test set
    • Multi-reader multi-case (MRMC) comparative effectiveness study
    • Stand-alone (algorithm only) performance
    • Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
    • Sample size for the training set
    • How the ground truth for the training set was established
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1