Search Results

The components of the Titanium Spinal Rod System are indicated for spinal fixation.

When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine(T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, multioperated back or revision of previous surgery.

When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, multi-operated back or revision of previous surgery.

When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/iliac screws, pedicle screws and connectors the levels of attachment are lumbar, thoracic and cervical spine and the sacrum and ilium. The device system using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 ioint, the levels of pedicle screw fixation may be L3-S1.

The components of the Titanium Spinal Rod System are indicated for spinal fixation. When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/iliac screws, pedicle screws and connectors the levels of attachment are lumbar, thoracic and cervical spine and the sacrum and ilium. These device components are for single use. Cementless or cement fixation is not applicable to these components. The material used is implant grade material that conforms to ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (Ti-6Al-4V).

The provided text is a 510(k) Pre-Market Notification for the Aurora Titanium Spinal Rod System. It describes the intended use, materials, and regulatory clearance of the device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, or ground truth establishment.

This document is a regulatory submission for a medical device (spinal rods and screws) and primarily focuses on demonstrating substantial equivalence to previously cleared devices. It outlines the specific indications for use and identifies the materials used. The FDA's response clarifies the limitations and warnings associated with pedicle screw use in particular.

Therefore, I cannot provide the requested table and study details as this information is not present in the provided text.

Ask a specific question about this device