Search Results

The NILE Alternative Fixation Spinal System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;

2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis:

3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The NILE Alternative Fixation Spinal System may also be used in conjunction with other medical implants made of similar metals whenever 'wiring' may help secure the attachment of other implants.

The NILE Alternative Fixation Spinal System implants are comprised of bands, clamps and set screws designed to attach to titanium or cobalt chrome rods. The band is manufactured from polyethylene terephthalate (PET) and the clamps and set screws are made from titanium alloy in accordance with ASTM F136. Once the bands are secured the stainless steel tips are detached and are not intended to be implanted.

Function: The NILE Alternative Fixation Spinal System is a band (tether) and clamp device that is designed to be used in conjunction with spinal rods for attachment to the posterior vertebral structures.

The purpose of this submission is to allow for sterile packaging of the NILE clamps.

This document is a 510(k) summary for the NILE Alternative Fixation Spinal System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain details about specific acceptance criteria, study designs, or performance metrics in the format requested.

The document states: "The NILE Alternative Fixation Spinal System implants were previously tested and compared to predicate devices. The NILE Alternative Fixation system implants performed equally to or better than these systems in static tensile strength, static and dynamic compression, dynamic tension/band pull-through, static band pull-through, axial gripping capacity and rotational gripping capacity. No modifications were made to the implants and therefore additional testing was not deemed necessary."

This implies that prior studies were conducted to establish performance, but the details of those studies (acceptance criteria, specific results, sample sizes, ground truth, etc.) are not present in this 510(k) summary.

Therefore, I cannot provide the requested table and study details. This document serves as an FDA clearance letter and summary, not a detailed study report.

Ask a specific question about this device