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510(k) Data Aggregation

    K Number
    K001277
    Device Name
    TRIFLANGE ACETABULAR CUP SYSTEM
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Date Cleared
    2000-06-23

    (63 days)

    Product Code
    LPH,MEH
    Regulation Number
    888.3358
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K952740,K962007,K983035,K972393,K980711
    Why did this record match?
    Device Name :

    TRIFLANGE ACETABULAR CUP SYSTEM

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

    The TriFlange™ Acetabular Cup System is intended to be used with the Duraloc® UHMWPE liners to resurface the acetabular socket in cementless application during total hip arthroplasty.

    The TriFlange™ Acetabular Cup System is indicated for use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged by disease, deformity, or trauma including non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant.

    Device Description

    The patient specific TriFlange™ Acetabular Cup System is an acetabular cup system designed and manufactured to match the individual patient's anatomy. The system consists of a porous coated Duraloc acetabular cup with three patient specific illial, ischial and pubic flanges added to reinforce weak acetabula similar to the Protrusio Cage. The device may be fixed in place with titanium bone screws of various lengths through a variety of screw holes in the flanges.

    AI/ML Overview

    This document is a 510(k) summary for a medical device called the "TriFlange™ Acetabular Cup System." It describes a hip implant and its intended uses, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    The 510(k) summary focuses on demonstrating "substantial equivalence" to other legally marketed devices, which is a regulatory pathway for medical devices in the US. It lists similar devices, describes the product, and states its intended use and indications for use. It also includes the FDA's letter of clearance.

    Therefore, I cannot provide the requested information. The document does not contain:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes used for test sets, data provenance, or details about training sets.
    3. Information about experts, ground truth establishment, or adjudication methods.
    4. Any mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.

    This document is purely for regulatory clearance and does not detail performance testing against specific acceptance criteria.

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