LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K190068
    Device Name
    Vanguard XP Knee System
    Manufacturer
    Zimmer Inc.
    Date Cleared
    2019-06-04

    (140 days)

    Product Code
    JWH,MBH,MBV,OIY
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K121771,K150090,K122160,K132873,K141407,K153657
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    1. Painful and disabled knee joint resulting from osteoarthritis, or traumatic arthritis, or traumatic arthritis where one or more compartments are involved.

    2. Correction of varus, valgus, or posttraumatic deformity.

    3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.

    Femoral components and tibial tray components with porous coatings are indicated for cemented biological fixation application. Non-coated (Interlok) femoral components and all polyethylene patellar components are indicated for cemented application only.

    Device Description

    The Vanguard XP Knee System is a total knee replacement system that consists of a femoral component composed of cobalt-chromium-molybdenum (Co-Cr-Mo), two styles of tibial trays manufactured out of Co-Cr-Mo (with locking bar), and dual bearings machined of Vivacit-E Vitamin-E Highly Crosslinked Polyethylene (VEHXPE). Biomet patellae can be used with the Vanguard XP Knee System. The subject Vanguard XP tibial components are available with a porous plasma spray (PPS®) of titanium alloy powder for uncemented or cemented fixation or with Biomet's Interlok coarse blasted finish for cemented fixation only. The Vanguard XP Knee System offers the flexibility to retain the ACL and PCL ligaments, retain just the PCL ligament and accommodate an intact, partially functioning PCL within a single system.

    AI/ML Overview

    The provided document, a 510(k) premarket notification for the Vanguard XP Knee System, primarily focuses on demonstrating substantial equivalence to predicate devices for a knee implant, specifically a modification to the tibial bearings. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an Artificial Intelligence (AI) / Machine Learning (ML) enabled medical device.

    The document discusses:

    • Device Identity: Vanguard XP Knee System, a total knee replacement system.
    • Modification: A modification to the tibial bearings within the system.
    • Purpose of Submission: To demonstrate that this modification does not adversely affect safety and efficacy and that the modified device remains substantially equivalent to predicate devices.
    • Testing: Engineering analysis and non-clinical tests (e.g., material characteristics, stress analysis, MRI compatibility, non-pyrogenicity).
    • Clinical Data: Explicitly states, "Clinical data was not deemed necessary for the subject device." This indicates that no human clinical study was conducted for this specific 510(k) submission, and certainly not a study related to AI/ML performance.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving an AI/ML device meets them based on the provided text. The document pertains to a traditional orthopedic implant, not an AI/ML medical device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1