Search Results
Found 1 results
510(k) Data Aggregation
(127 days)
The Invictus® Bands System consists of temporary implants 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:
- Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
- 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;
- Spinal degenerative surgery, as an adjunct to spinal fusions;
- Use with a posterior spinal instrumentation construct when ligament augmentation is needed.
The Invictus® Bands System may also be used in conjunction with other medical implants made of commercially pure titanium, titanium alloy, or cobalt chrome whenever "wiring" may help secure the attachment of other implants.
The Invictus® Bands System is a sublaminar fixation and ligament augmentation system consisting of bands, sleeves, connectors, and set screws that mate with 4.5 – 5.0 mm and 5.5 – 6.0 mm diameter rods. The Invictus® Bands System sleeves, connectors, and set screws are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The bands are comprised of a polyethylene terephthalate (PET) braid with a stainless steel malleable tip and needle (leads) at the ends of the bands. The stainless steel leads are detached after insertion and are not intended to be implanted. Implants are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.
The Invictus® Bands System connectors accept various rod diameters and are appropriate for use with any 4.5 – 5.0 mm and 5.5 – 6.0 mm diameter rod-based spinal fixation system cleared by FDA.
The bands are for single use and are provided terminally sterile via gamma irradiation. The sleeves, connectors, and set screws are for single use and are provided non-sterile to be steam sterilized by the end user. The system includes class I, reusable surgical instruments made of stainless steel and other materials and are provided non-sterile to be cleaned and steam sterilized by the end user.
N/A
Ask a specific question about this device
Page 1 of 1