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510(k) Data Aggregation

    K Number
    K233670
    Device Name
    Ascension Silicone MCP; Ascension Silicone PIP
    Manufacturer
    Ascension Orthopedics, Inc.
    Date Cleared
    2023-12-14

    (29 days)

    Product Code
    KYJ
    Regulation Number
    888.3230
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K022892,K082231
    Why did this record match?
    Device Name :

    Ascension Silicone MCP; Ascension Silicone PIP

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

    The ASCENSION Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.

    The ASCENSION Silicone MCP implant is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.

    Device Description

    The ASCENSION Silicone MCP and PIP implants are anatomically designed, single-use, one-piece, flexible hinge prostheses designed to be implanted without bone cement across the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joint. They are made from medical grade silicone elastomer. The proximal and distal stems of the prostheses are pre-flexed to match the approximate natural flexion position of the joint when the hand is relaxed. The MCP and PIP implants provide 90 degrees of flexion from full extension.

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the Ascension Silicone MCP and Ascension Silicone PIP devices. This document focuses on the regulatory clearance of a physical medical device (finger joint prostheses) based on a special 510(k) for adding "MR Safe" labeling.

    The information you've requested (acceptance criteria and study details for an AI/software device) is not present in this document. The document explicitly states:

    • "Non-clinical performance data is not required to support the addition of MR Safe labeling to the subject devices."
    • The determination of "MR Safe" was established through a "scientific rationale that addressed information about the electrical conductivity and magnetic properties of the device material per the FDA guidance document 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.'"

    Therefore, I cannot provide the requested details because the device in question is not an AI/software medical device that underwent the type of performance study you're asking about.

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