(82 days)
The Talon™ DistalFix™ Antegrade Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the femur including:
- · Femoral shaft fractures
- · Ipsilateral femur fractures
- · Supracondylar fractures, including those with intra-articular extension
- · Osteoporotic fractures
- · Pathologic/impending pathologic fractures
- · Malunions/nonunions
The device is intended to stabilize fragments of the fracture until bony union can occur.
The Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail is used for fixation and stabilization of fractures of the femur until bony union can occur. The Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail may be inserted into the femoral canal using either an antegrade or retrograde surgical approach. The system consists of the following parts:
- A femoral nail with proximal portals for passage of cortical locking screws and distal portals that allow passage of deployable integral talons to achieve distal fixation from within the intramedullary canal. The distal talons may be retracted for removal of the intramedullary nail if and when it is necessary. The nail will be provided in a pre-assembled condition with the deployable distal nail talons and distal end cap already installed.
- Cortical locking screws will be provided separately. The cortical locking screws are provided for proximal fixation if desired.
- Universal cortical locking screws will be provided separately. The universal cortical locking screws provide increased purchase in cancellous bone and are provided for proximal fixation if desired.
- A proximal end cap will be provided separately. The end cap prevents bony ingrowth and preserves the threads which may be used for attachment of instrumentation during explantation of the nail.
ODi-NA will manufacture the implants from implant grade titanium alloy.
The provided text is a 510(k) premarket notification for a medical device called the Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail System. It describes the device, its indications for use, and claims substantial equivalence to a predicate device.
However, the document does not contain the detailed acceptance criteria for a study proving device performance, nor does it describe a study with the specific elements requested in your prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone algorithm performance, training set details, or how ground truth was established for a training set).
The document states:
- "Mechanical Data: Review of the mechanical test data indicates the Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail is substantially equivalent to the previously cleared Stryker® T2 Femoral Nail System (K112059, K081152, K021744)."
This sentence indicates that mechanical testing was performed, and the results were reviewed to demonstrate substantial equivalence to a predicate device. However, the details of these mechanical tests, including specific acceptance criteria and the results comparing the Talon™ DistalFix™ system to these criteria, are not provided in this document.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed study as requested, as that information is not present in the provided text. The document primarily focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study with the metrics you've outlined.
§ 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.