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510(k) Data Aggregation

    K Number
    K120871
    Device Name
    SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    2012-06-07

    (77 days)

    Product Code
    JDW,KTT,LXT,OSN
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K870961,K920024,K953397,K962808,K970713,K970751,K970748,K994143,K023134,K023921,K031181,K033289,K042312,K042436,K072212,K090926,K093047,K110069
    Why did this record match?
    Reference Devices :

    K870961,K920024,K953397,K962808,K970713,K970751,K970748,K994143,K023134,K023921,K031181,K033289,K042312

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

    The Smith & Nephew, Inc. External Fixation Instrumentation is intended for use in:

    1. Post-Traumatic joint contracture which has resulted in loss of range of motion ( not applicable for Smith & Nephew Rail System)
    2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
    3. Open and closed fracture fixation
    4. Pseudoarthrosis of long bones
    5. Limb lengthening by epiphyseal or metaphyseal distraction (not applicable for COMPASS Universal Hinge or JET-X Fixator)
    6. Correction of bony or soft tissue deformities (not applicable for COMPASS Universal Hinge)
    7. Correction of segmental bony or soft tissue defects
    8. Joint arthrodesis (not applicable for Smith & Nephew Rail System)
    9. Infected fractures or nonunions
    10. Mini external fixator systems are indicated for the management of comminuted intraarticular fractures of the distal radius (not applicable for Smith & Nephew Rail System)
    11. Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints. As well as some select fractures, nonunion, or osteotomy of the distal tibia; and acute transverse fractures or nonunion of the distal tibia (not applicable for Smith & Nephew Rail System)
    Device Description

    Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. External Fixation Instrumentation. The subject devices are accessory devices and are intended to be used to assist in the implantation of the Smith & Nephew External Fixation Systems and their cleared Indications for Use. Smith & Nephew External Fixation Instruments can be organized into instrument families which are categorized as follows: Tightening/Insertion, Alignment, Guides, and Drills.

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification for the "Smith & Nephew, Inc. External Fixation Instrumentation." This submission is for surgical instruments, not a device that generates performance metrics in the way an AI diagnostic or therapeutic device would.

    Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment is not applicable to this type of regulatory submission.

    This 510(k) submission establishes substantial equivalence to legally marketed predicate devices based on similarities in:

    • Raw materials
    • Manufacturing processes
    • Sterilization procedures
    • Nature of body contact
    • Design and function

    The FDA's review for this type of device focuses on ensuring these accessory instruments are safe and effective for their intended use alongside the cleared Smith & Nephew External Fixation Systems, and that they are substantially equivalent to existing predicate instruments. It does not involve a performance study with quantitative acceptance criteria as would be expected for a diagnostic or AI-driven device.

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