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K Number
K092646
Device Name
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW
Manufacturer
SYNTHES (USA)
Date Cleared
2009-09-25

(28 days)

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

As part of the Synthes Trochanteric Fixation Nail (TFN) System, the Synthes TFN Screw 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 TFN 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

The Synthes TFN Screw is a threaded component composed of titanium alloy which is intended for use with Synthes Trochanteric Fixation Nails to provide stabilization of fractures of the proximal femur.

AI/ML Overview

This document is a 510(k) summary for the Synthes (USA) Trochanteric Fixation Nail (TFN) Screw. It is a regulatory submission for a medical device and, as such, outlines the device's technical specifications, intended use, and substantial equivalence to predicate devices. It does not present a study proving the device meets acceptance criteria in the context of an AI/software as a medical device (SaMD) or diagnostic tool.

Therefore, I cannot provide the requested information about acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies because this document does not contain that type of information.

The document is a filing for an orthopedic screw, a physical medical device, not a diagnostic or AI-powered system that would typically undergo performance studies with the metrics you've listed.

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.