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510(k) Data Aggregation

    K Number
    K992144
    Device Name
    BIOPRO RIMMED ACETABULAR COMPOMENT
    Manufacturer
    BIOLOGICALLY ORIENTED PROSTHESES
    Date Cleared
    1999-09-22

    (90 days)

    Product Code
    LZO
    Regulation Number
    888.3353
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOPRO RIMMED ACETABULAR COMPOMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Osteoarthritis
    2. Rheumatoid arthritis with severe hip pain and limited joint motion.
    3. Avascular necrosis
    4. Traumatic arthritis
    5. Acetabular cavity deformities caused by congenital problems.
    6. Revisional surgery after one or more total hip operations.
    7. Fixation with bone cement and/or cancellous bone screws.
    Device Description

    The rimmed acetabular component is manufactured of Titanium 6 A1-4V Bli (ASTM F136). It is available in five sizes: 54mm, 58mm, 64mm, 70mm, and 76mm. The BioPro rimmed acetabular component accommodates BioPro's 28nun and 32mm Cox Comb inserts: 28x55 (10068), 28x58 (10069), 28x65 (10071), 28x69 (10074), 28x75 (11227), 32x55 (10077), 32x58 (10078), 32x65 (10081), 32x69 (10083), and 32x75 (10084).

    AI/ML Overview

    This document is a 510(k) summary for the BioPro Rimmed Acetabular Component, detailing its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document focuses on regulatory approval based on equivalence rather than performance testing against specific criteria.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. This type of information is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) summary.

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