(101 days)
The Talon™ DistalFix™ Proximal Femoral Nail's primary indications are for the fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, high subtrochanteric fractures (without shaft extension), and combinations of these fractures. The long nail allows the additional indication of low subtrochanteric fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.
The Talon™ DistalFix™ Proximal Femoral Nail is used for fixation and stabilization of fractures of the proximal femur until bony union can occur. The system consists of the following parts:
- . A femoral nail with a proximal portal for passage of a lag screw and distal portals that allow passage of deployable intearal 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, distal end cap and integral lock screw subassembly already installed.
- . A Talon™ lag screw with proximal portals for passage of deployable talons to increase the purchase of the lag screw within the femoral neck/head. These talons may also be retracted for removal of the lag screw if and when it is necessary. The lag screw is cannulated and keyed with tapered flats on the distal This keyed shaft allows the option of static, compression, or axial end.
- 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 allov.
This document does not describe acceptance criteria, performance data, or a clinical study for the device. Instead, it is a 510(k) summary and an FDA clearance letter for the "Talon™ DistalFix™ Proximal Femoral Nail System."
The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to an already legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through a new clinical trial with specific performance metrics.
The document states:
- "Review of the mechanical test data indicates the Talon™ DistalFix™ Proximal Femoral Nail is substantially equivalent to the previously cleared ODi nails (K033286 and K014189)." This suggests that mechanical testing was performed to demonstrate that the new device performs similarly to predicate devices, but it does not provide specific acceptance criteria or reported performance values.
- Predicate Devices: The submission relies on substantial equivalence to the Stryker® Gamma3™ Nail System (K043431, K034002, K032244), Orthopedic Designs (ODi) Talon™ Intramedullary Hip Nail (K014189), and Orthopedic Designs (ODi) Talon™ Long Proximal Femoral Nail System (K033286). The assumption is that since these predicate devices are already cleared, and the new device is substantially equivalent, it also meets appropriate safety and performance standards.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because this type of information is generally NOT required or provided in a 510(k) summary for a substantial equivalence determination based on predicate devices and mechanical testing, unless there are unique technological characteristics or new indications for use that warrant clinical data.
§ 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.