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510(k) Data Aggregation

    K Number
    K040544
    Device Name
    DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062
    Manufacturer
    DEPUY, INC.
    Date Cleared
    2004-05-28

    (87 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K920317,K893872,K883460,K860701,K891082,K011533,K980513,K001534,K961186
    Why did this record match?
    Reference Devices :

    K920317, K893872, K883460, K860701, K891082, K011533, K980513

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

    The Duraloc® Option Acetabular Cup System is for total hip replacement.

    A total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

      1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
    • Avascular necrosis of the femoral head. 2.
    • Acute traumatic fracture of the femoral head or neck. 3.
    • Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
      1. Certain cases of ankylosis.

    The acetabular cups are indicated for cementless application.

    Device Description

    The Duraloc® Option Acctabular Cup System consists of a UHMWPE acetabular cup liner secured to a porous-coated Ti-6A1-4V acetabular shell. The acetabular system articulates with previously cleared 28mm fernoral heads, as well as with 22.225mm femoral heads internally documented by DePuy as line extensions to femoral heads cleared in K920317 and K980513.

    The 28mm femoral heads were cleared in K920317 on March 19, 1992, K893872 on July 11, 1989, K883460 on October 11, 1998, K860701 on March 19, 1986, K891082 on June 9, 1989 and K011533 on January 28, 2002.

    The acetabular cups are sized from 46mm to 66mm, in 2 mm increments. The liners are available in two styles: neutral and lipped. Liners with a 22,225mm inner diameter are offered in the outer diameter of 46mm. Liners with a 28mm inner diameter are offered in outer diameters of 48/50mm, 52mm, 54/56mm, 58/60mm, and 62/64/66mm.

    The liner interlock allows the liner to be rotated to match the patient's anatomy. A locking ring, manufactured from Co-Cr-W-Ni alloy, is used to secure the liner.

    The cups and liners are intended to be used in total hip arthroplasty to provide increased patient mobility and to reduce pain by replacing damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components.

    The acetabular cups are indicated for cementless application.

    AI/ML Overview

    The provided text describes a 510(k) summary for a medical device, the Duraloc® Option Acetabular Cup System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving device efficacy through clinical studies with acceptance criteria in the way a new drug or novel medical device might.

    The 510(k) summary does not include:

    • Acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) for an AI/CADe device.
    • Details of a study proving the device meets specific performance acceptance criteria.
    • Information on sample sizes, ground truth establishment, expert qualifications, or adjudication methods for a diagnostic algorithm.
    • Any mention of AI, CADe, or image analysis.
    • Multireader multi-case (MRMC) studies or standalone performance studies.

    Instead, the document focuses on:

    • Substantial Equivalence: Comparing the Duraloc® Option Acetabular Cup System to previously cleared hip prosthesis devices (DePuy Pinnacle Acetabular System and DePuy Duraloc Cementless Acetabular Cup System).
    • Device Description: Detailing the components and materials of the acetabular cup system.
    • Intended Use and Indications: Specifying the conditions for which the device is intended, which are related to total hip arthroplasty to replace damaged hip joint articulation in various severe conditions like osteoarthritis, traumatic arthritis, avascular necrosis, etc.

    Therefore, it is not possible to answer the detailed questions about acceptance criteria, study design, expert involvement, or AI performance based on the provided text. The document pertains to a hardware medical device (hip prosthesis) seeking 510(k) clearance, not a software/AI medical device that would have performance metrics like those requested in the prompt.

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