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510(k) Data Aggregation

    K Number
    K150576
    Device Name
    TGM Biolox delta Ceramic Heads
    Manufacturer
    TGM MEDICAL, INC.
    Date Cleared
    2015-09-09

    (187 days)

    Product Code
    LZO
    Regulation Number
    888.3353
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K111472,K121636,K131684
    Why did this record match?
    Reference Devices :

    K111472, K121636

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

    TGM Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components of compatible TGM Medical systems in cases of:

    A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.

    B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.

    C. Proximal femoral fractures.

    D. Avascular necrosis of the femoral head.

    E. Non-union of proximal femoral neck fractures.

    F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valea, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.

    Device Description

    The Biolox® delta Ceramic Heads are modular femoral components used in hip arthroplasty. The head attaches to a femoral stem via a 12/14 Morse taper and articulates with a polyethylene acetabular component. The ceramic material is Transition-Toughened-Platelet Alumina (TTPA) consisting of 75% Alumina, 24% Zirconia and 1% Platelet. The heads are available in three diameters (28, 32 & 36mm) and a variety of offsets.

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information available regarding acceptance criteria or a study that proves a device meets such criteria to address your detailed request about performance, sample size, ground truth, or expert involvement in a medical device study.

    The document is a 510(k) premarket notification summary for "TGM Biolox® delta Ceramic Heads." It primarily focuses on demonstrating substantial equivalence to predicate devices for marketing authorization, not on providing detailed performance studies against specific acceptance criteria.

    Specifically, under "Clinical testing," the document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification."

    Therefore, I cannot extract the information required to populate a table of acceptance criteria, describe a study on device performance, or detail aspects like sample size, ground truth, or expert involvement, as these were not part of the submission described.

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