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510(k) Data Aggregation

    K Number
    K193366
    Device Name
    T2 ICF
    Manufacturer
    Stryker GmbH
    Date Cleared
    2020-03-20

    (107 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K191412,K081071,K180024
    Why did this record match?
    Reference Devices :

    K191412

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

    The T2 ICF System is indicated for internal bone fixation of the following conditions and procedures:

    • · Neuropathic osteoarthropathy (Charcot)
    • · Fracture fixation
    • · Osteotomies
    • · Non-unions
    • · Mal-unions
    • · Fusions
    Device Description

    The T2 ICF System is a cannulated intramedullary nail system intended for internal fixation and stabilization of various foot instabilities and reconstructions. The T2 ICF system includes sterile packed implants (intramedullary nails and endcaps) available in various diameters and lengths to better accommodate patient anatomy as well as non-sterile instrumentation (targeting devices). The intramedullary nails are assembled with a pre-loaded compression screw, which allows for the nail to compress the bony fragments. The sterile packed intramedullary nails (including the preloaded compression screw) and endcaps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136.

    Additionally, the T2 ICF System will be used with an existing subset of VariAx 2 bone screws (previously cleared under K191412) to achieve fixation of the nail.

    Lastly, the T2 ICF System will be used with several existing Class I 510(k) exempt devices for various orthopedic purposes.

    AI/ML Overview

    This document describes the T2 ICF System, a cannulated intramedullary nail system for internal bone fixation. Since the provided text is an FDA 510(k) summary, it details the substantial equivalence of the device to existing predicate devices, rather than presenting a study proving acceptance criteria for a novel AI device or software. Therefore, many of the requested categories related to AI performance metrics, ground truth, and expert evaluation are not directly applicable.

    Here's an analysis of the provided information within the context of your request, focusing on what is available:

    1. A table of acceptance criteria and the reported device performance

    The document does not explicitly state "acceptance criteria" in the traditional sense for an AI/software device. Instead, it describes bench testing conducted to demonstrate "substantial equivalence" to predicate devices. The performance is reported in terms of successfully meeting the requirements of these tests to prove equivalence.

    Acceptance Criteria (Implied by Substantial Equivalence Bench Testing)Reported Device Performance
    Biocompatibility: Meet requirements of ISO 10993-1, ISO 10993-5, ISO 10993-12, ISO 10993-18.Testing demonstrated compliance with biocompatibility standards.
    Bacterial Endotoxin Testing (Pyrogenicity): Achieve an Endotoxin limit of
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