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510(k) Data Aggregation

    K Number
    K011857
    Device Name
    SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2001-09-12

    (90 days)

    Product Code
    HSB,HWC
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K093089,K120083,K182783,K203811,K230456,K233150
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Synthes Trochanteric Fixation Nail (TFN) System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long Trochanteric Fixation Nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.

    Device Description

    Synthes (USA) Trochanteric Fixation Nail (TFN) System consists of a cannulated intermedullary nail, a cannulated helical blade and cannulated nail end cap. The TFN Nail is anatomically contoured with a proximal diameter of 17 mm, tapering to a nominal diameter of 10, 11 or 12 mm. The tuporing locking hole accommodates angles ranging from t 125 - 135°. TFN nails arc to be available in short lengths (170 - 235 mm) and long lengths (300 - 460 mm), with the long length nails available in right or left versions. The Trochanteric Fixation Nail accepts commercially available Synthes 4.9 mm Locking Bolts and/or 5.0 mm Locking Screws.

    AI/ML Overview

    The provided text is a 510(k) premarket notification for a medical device (Synthes (USA) Trochanteric Fixation Nail System), which is a device for fixing bone fractures. It describes the device itself, its intended use, and the FDA's clearance of the device as substantially equivalent to a predicate device.

    However, the text does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. These details are typically found in the scientific validation section of a full regulatory submission, which is not provided in these excerpts.

    Therefore,Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter and associated summary, which focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results.

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