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The Invictus Spinal Fixation System is intended for non-cervical posterior and anterolateral fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis (i.e., scoliosis, kyphosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatic patients diagnosed with the following conditions: spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach.

The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.

Invictus SI.CORE Screws are intended for sacroiliac joint fusion for the following conditions:

· Sacroliac joint dysfunction that is a direct result of sacrolliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.

· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patropelvic fixation as part of a lumbar or thoracolumbar fusion.

· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

Invictus CORE and Invictus SI.CORE Screws are not intended for use with cement; all other fenestrated screws may be used with Invictus Bone Cement. When used in conjunction with Invictus Bone Cement, the Invictus Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Invictus Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The Invictus Spinal Fixation System is thoracolumbosacral spinal fixation system designed to be implanted through a non-cervical posterior or anterolateral surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine. Invictus SI.CORE bone screws are intended to provide sacroiliac joint fusion in sacral alar iliac (SAI) trajectories. Invictus Core and Invictus SI.Core Screws are not intended for use with cement; all other fenestrated screws may be with Invictus Bone Cement, a self-hardening and ready to use used polymethylmethacrylate (PMMA) bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty.

The Invictus Patient Specific Rods are used to connect pedicle screws, hooks, and connectors across different levels of vertebral bodies to create a rigid construct. They are intended to be used with standard Invictus instrumentation. The Invictus Patient Specific Rods are available in 05.5 mm and 6.0 mm diameters and will be provided in lengths between 20 - 600 mm. Equivalent to cleared Invictus rod materials, the rods are made from five different materials: Commercially Pure Titanium (CP Ti Grade 4), Titanium Alloy (Ti-6Al-4V ELI), and three different formulations of Cobalt Chromium (Co-28Cr-6Mo). All Invictus Patient Specific Rods are provided pre-contoured to the surgeon's plan based on the patient's anatomy by means of an industrial bending process prior to distribution for surgery. There is no need for additional bending during surgery.

The purpose of this submission is to expand indications for use of Invictus SI.CORE screws as sacroiliac joint fusion devices, and to add a range of Invictus Patient-Specific Rods to the Invictus Spinal Fixation System.

The provided text is a 510(k) premarket notification letter and summary for the Invictus® Spinal Fixation System. It focuses on establishing substantial equivalence to previously cleared predicate devices through engineering analysis and rationale, primarily for the expansion of indications for use for Invictus SI.CORE screws and the addition of Invictus Patient-Specific Rods.

This document explicitly states: "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies cannot be found within this document. This 510(k) submission relied on non-clinical data (engineering analysis and rationale) to demonstrate substantial equivalence.

To answer your prompt, I would need a different type of document, such as a clinical study report or a different section of a regulatory submission that details performance testing against specific acceptance criteria.

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