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510(k) Data Aggregation

    K Number
    K002883
    Device Name
    PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Date Cleared
    2000-10-13

    (28 days)

    Product Code
    KWA,JDM
    Regulation Number
    888.3330
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K001083,K021382
    Why did this record match?
    Reference Devices :

    K001083, K021382

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

    The Pinnacle Metal-On-Metal Acetabular Cup Liners are indicated for use as the acetabular component in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

    The Pinnacle Metal-On-Metal Acetabular Cup Liners are intended for use with DePuy Pinnacle Acetabular Shells and 28mm diameter Co-Cr-Mo femoral heads only.

    Device Description

    The Pinnacle Metal-On-Metal (MOM) Acetabular Cup Liner is a metal liner that is intended for use with the Pinnacle Acetabular Shells that have been cleared previously. The liner has a 28mm inner diameter and is offered in a neutral style only. The Pinnacle MOM liner is mechanically locked with the shell via a taper junction, and articulates with commercially available prosthetic femoral heads.

    AI/ML Overview

    This document is a 510(k) summary for the DePuy Pinnacle Metal-On-Metal Acetabular Cup Liners. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. Therefore, it does not contain a study proving the device meets acceptance criteria.

    The document states: "The Pinnacle Metal-On-Metal Acetabular Cup Liners are nearly identical to the Ultima Metal-On-Metal Acetabular Cup Liners that were cleared previously. The intended use, articular surface, material and locking mechanism with the outer shell are the same. The only changes are minor design changes that allow the liners to be used with the Pinnacle Acetabular Shells that have been cleared previously."

    This statement indicates that the device's acceptance is based on its substantial equivalence to an already approved device (DePuy Ultima Metal-On-Metal Acetabular Cup Liners), rather than a new study with specific acceptance criteria and performance metrics detailed here.

    Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria, as this document is not a study report.

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