LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K081620
    Device Name
    MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Date Cleared
    2008-06-30

    (21 days)

    Product Code
    KWS,HSD,PHX
    Regulation Number
    888.3660
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K062250,K073676
    Why did this record match?
    Device Name :

    MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM

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

    The Delta Xtend Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint.

    The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

    In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cases where the residual bone permits firm fixation of this implant.

    Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision of a previously failed Delta Xtend Reverse Shoulder.

    The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.

    The modular humeral stem and epiphysis components are HA coated and intended for cementless use.

    All other components are for cemented use only.

    The Delta Xtend Reverse Shoulder prosthesis is intended for use in total or hemi shoulder arthroplasty procedures in patients with non-functional rotator cuffs, with or without bone cement. HA coated components are for cementless use only.

    Device Description

    The Delta Xtend Reverse Shoulder System is a modular shoulder prosthesis designed for use in patients with non-functional rotator cuffs.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, reported device performance, sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details. This document is a 510(k) premarket notification letter and summary for a medical device (DePuy Delta Xtend Reverse Shoulder System), which primarily focuses on establishing substantial equivalence to existing predicate devices based on design, materials, and intended use, rather than presenting detailed study results for performance metrics.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1