(90 days)
The ODi Talon™ Intramedullary Hip Nail will be used on indications that are common with presently marketed intramedullary hip nail systems. The primary indications are for fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.
The ODi Talon™ Intramedullary Hip 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:
- An intramedullary nail with portals that allow passage of distal cortical screws . and a proximal lag screw assembly. The nail will be provided in a pre-assembled condition with the sleeve lock and end cap already attached to save time in surgery.
- The Talon™ Lag Screw is completely compatible with ODi's Talon™ ● Compression Hip Screw system and has been previously approved by the FDA in K984331. The Talon™ lag screw has deployable tangs to increase the purchase of the lag screw within the femoral neck/head. These tangs may also be retracted for removal of the lag screw if and when it is necessary. The distal end of the lag screw is keyed with a "double-d" shape, cannulated and internally threaded. This keyed shaft provides rotational stability for better lag screw purchase. The screw is internally threaded to allow the use of the compression screw to compress the fracture fragments.
- A slotted sleeve which passes through the intramedullary nail. The sleeve is . keyed to the lag screw assembly to prevent its rotation while allowing axial translation of the lag screw.
- A sleeve lock which passes through the proximal end inner bore of the ● intramedullary nail. The sleeve lock has 2 positions within the intramedullary nail - "locked" and "unlocked". In the "locked" position, the legs on the sleeve lock mate with the slots in the sleeve thereby preventing rotation and axial translation of the sleeve, but allowing axial translation of the lag screw assembly. The sleeve lock is provided for surgery pre-assembled in the "unlocked" position within the intramedullary nail.
- A compression screw which shoulders against the slotted sleeve and engages . the internal threads in the distal end of the lag screw assembly providing for axial compression of a proximal hip fracture. A polyethylene patch is embedded in the threaded portion of the compression screw to prevent rotation of the screw inside the lag screw after the desired amount of compression is reached.. The compression screw is used to compress the fracture site by drawing the nail and lag screw portions together. The compression screw has been previously approved by the FDA in K984331.
- An end cap with both internal and external threads and a keying slot. The . external threads engage the internal threads in the proximal end of the intramedullary nail and protect them from bony ingrowth for the possible future attachment of nail removal instrumentation for explantation. The internal threads in the end cap mate with the nail installation instrumentation. The end cap is provided for surgery pre-assembled in the intramedullary nail.
- Cortical screws are provided to cross-lock the distal end of the nail to the . femoral shaft to help prevent axial translation of the nail. The cortical screws have been previously approved by the FDA in K984331.
The nail will be provided in a pre-assembled condition with the sleeve lock and end cap already attached to save time in surgery.
ODi will manufacture the implants from implant grade stainless steels.
The provided text is a 510(k) summary for the ODi Talon™ Intramedullary Hip Nail. However, it does not contain any information regarding acceptance criteria, study design, or device performance metrics that would allow for the completion of the requested table and study details.
The document primarily focuses on:
- Regulatory information: Company contact, classification, and device product code.
- Device description: Detailed breakdown of the components of the intramedullary hip nail system.
- FDA clearance: A letter from the FDA stating substantial equivalence to a predicate device.
- Indications for Use and Contra-Indications: Clinical scenarios for which the device is intended and not intended.
To complete the request, information from a performance study demonstrating how the device met specific acceptance criteria would be necessary. This type of information is typically found in design validation or verification reports, which are not part of a standard 510(k) summary provided to the public.
Therefore, I cannot provide the requested table or study details based on the input text.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.