LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K233674
    Device Name
    Freedom Wrist Arthroplasty System
    Manufacturer
    Ascension Orthopedics, Inc.
    Date Cleared
    2024-05-30

    (196 days)

    Product Code
    JWJ
    Regulation Number
    888.3800
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K132250
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Freedom Wrist Arthroplasty System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. The Freedom Wrist Arthroplasty System is intended for cemented use.

    Device Description

    The Freedom Wrist Arthroplasty System consists of components to replace the articulation of the distal radius and proximal row of carpal bones of the wrist joint. The components are intented together as a system, not individually as hemi-arthroplasty components. The radial component is made of Cobalt Chrome Molybenum Alloy (CrCoMo) and has a concave articulating surface and is fixed by means of a stem which is inserted into the radial intramedullary canal. The carpal implant is an assembly consisting of a titanium carpal plate, which is fixed into the carpal bones with a cemented central peg and locking caps. A convex Ultra-High-Molecular-Weight Polyethylene (UHMWPE) bearing is locked onto the carpal plate to articulate with the radial component.

    AI/ML Overview

    Unfortunately, the provided text does not contain information about an AI/ML-based medical device study. The document is an FDA 510(k) clearance letter for the "Freedom Wrist Arthroplasty System," which is a physical medical device (a wrist implant).

    The text primarily focuses on:

    • Device Description: The components and materials of the wrist implant.
    • Intended Use/Indications for Use: What the implant is designed to treat.
    • Predicate Device Comparison: How it compares to previously cleared devices.
    • Non-Clinical Testing: Specifically, tests related to MRI safety and compatibility (Magnetically Induced Displacement Force, Torque, RF-Induced Heating, Image Artifacts).

    Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or specific performance metrics for an AI/ML device, as this information is not present in the provided document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1