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510(k) Data Aggregation

    K Number
    K001738

    Validate with FDA (Live)

    Device Name
    DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Date Cleared
    2000-12-27

    (203 days)

    Product Code
    FTM,SUR
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K982330,K980431,K973170,K993948,K992159,K983162,K970561,K974540
    Predicate For
    K020049,K021056,K021637,K031188,K031969,K033671,K043388,K052830,K061892,K082079
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DePuy Restore Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. In addition, the implant is intended for use in the specific application of reinforcement of the soft tissues which are repaired by suture or suture anchors limited to the supraspinatus during rotator cuff repair surgery.

    Device Description

    The Restore Orthobiologic Soft Tissue Implant is a round device, manufactured from 10 plys of Small Intestine Submucosa, (SIS). SIS is a biomaterial derived from porcine small intestine. SIS is composed predominately of water and collagen. This material is identical to the material approved K982330 for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample size, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.

    The document is a 510(k) summary for a surgical mesh device, focusing on its substantial equivalence to previously marketed devices. It describes the device, its intended use, and the basis for substantial equivalence but does not include any performance studies or validation data against specific acceptance criteria.

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