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510(k) Data Aggregation

    K Number
    K250315
    Device Name
    RONAVIS – FX (FX-001)
    Manufacturer
    AIRS Inc.
    Date Cleared
    2025-08-01

    (178 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RONAVIS – FX (FX-001)

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

    The RONAVIS-FX is intended to be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system and for temporary bone stabilization (

    Device Description

    The RONAVIS-FX is an external fixation device configured as a pin, which is inserted into the bone unicortically during orthopedic procedures. It consists of three components: a sleeve, an inner pin, and an anchor head. It is made of SUS316L and is provided non-sterilized. It should be sterilized by the user before use and is prohibited from being reused.

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a medical device called RONAVIS-FX. This letter does not contain any information regarding clinical studies, acceptance criteria for an AI/algorithm, or the performance of such an AI/algorithm. It pertains to a physical medical device (an anchor pin) for bone fixation, not a digital health product or an AI-based diagnostic tool.

    Therefore, I cannot fulfill the request for information regarding a study that proves the device meets acceptance criteria for an AI/algorithm, as the provided input does not describe such a device or study.

    The document discusses:

    • Device Type: Smooth or Threaded Metallic Bone Fixation Fastener (an anchor pin).
    • Indications for Use: Applied to the skeletal system for pulling force (traction) and temporary bone stabilization (
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