LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K201047
    Device Name
    Fusion Taper System
    Manufacturer
    Signature Orthopaedics Pty Ltd.
    Date Cleared
    2021-04-16

    (360 days)

    Product Code
    LZO,MBL,MEH
    Regulation Number
    888.3353
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K121297,K133370,K163625,K201278,K073567,K143184,K190704
    Why did this record match?
    Device Name :

    Fusion Taper System

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

    Signature Orthopaedics' Fusion Taper System is intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

    • . Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
    • . Inflammatory joint disease including rheumatoid arthritis
    • . Correction of functional deformity including congenital hip dysplasia
    • . Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
    • . Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemi-arthroplasty, surface replacement, or total replacement
      Signature Orthopaedics' Fusion Taper System is intended for cementless fixation only.
    Device Description

    The Fusion Taper System consists of modular femoral heads and taper sleeves. The Fusion Taper Sleeve is manufactured from Ti6Al4V as per ISO 5832-3. The Fusion Ceramic Head is manufactured from an alumina matrix as per ISO 6474-2. All Fusion Heads are intended for total hip arthroplasty. The Fusion Heads connect to the femoral stem via a Fusion Taper Sleeve which has a 12/14 inner taper and 16/18 outer taper. Signature Orthopaedics Fusion Taper System is indicated for use with Signature Ti6A14V femoral stems: TSI Stem (K102172), Origin Stem (K121297. K161155), Aria Stem (K121297), Remedy Stem (K133370), Spartan Stem (K192883), World Stem (K201278), and acetabular components: Logical Cup (K121297, K153131), Logical Liners (K121297), Logical 20deg Hooded Liners including lateralised variants (K153131), World Cup (K201278), and World Liner (K201278).

    AI/ML Overview

    This document is a 510(k) summary for the Signature Orthopaedics Fusion Taper System, a hip replacement prosthesis. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It does not describe an AI/ML device or a study proving that such a device meets acceptance criteria.

    Therefore, I cannot extract the requested information regarding acceptance criteria and studies related to an AI/ML device from this document. The document describes a physical medical device (hip implant components) and its non-clinical testing for regulatory clearance.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1