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The Thorocolumbar Spinal System consists of single use devices designed to aid in the surgical correction of several types of spinal conditions by providing stabilization until a solid spinal fusion develops.

When used as a pedicle screw system, the Thorocolumbar Spinal System when used in constructs with screws or spinal bolts placed in the pedicle are intended only for: grades 3 or 4 spondylolisthesis at the fifth lumbar-first sacral vertebral (LS-S1) joint: who are receiving fusion using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of solid fusion.

When used as a posterior hook and sacral/iliac screw fixation system only, the Thorocolumbar Spinal System is indicated for:

Scoliotic, lordotic, or kyphotic deformities

ddd ((defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

• pseudarthrosis stenosis spondylolisthesis (grade 1 or 2) fracture tumor resection
  As a posterior system, it is limited to non-cervical posterior use with the levels of posterior screw fixation from L3-S1.

As an anterolateral spinal system the indications are for anterior stabilization of levels T10 to L5 of the spine following: degenerative disc disease (defined above), tumor resection, spondylolisthesis, spondylolysis, fracture, pseudoarthrosis, and multi-operated back; and to correct lordotic and kyphotic spinal deformities.

The levels of anterolateral use are T10-L5.

The Thorocolumbar Spinal System consists of single use devices designed to aid in the surgical correction of several types of spinal conditions by providing stabilization until a solid spinal fusion develops.

This document describes a spinal system, not an AI/ML powered medical device. Therefore, the requested information about acceptance criteria, study design, ground truth, and expert involvement for an AI/ML device is not applicable to this text. The document focuses on the indications for use and general safety/effectiveness of a Thorocolumbar Spinal System, stating that testing involved comparison to substantially equivalent devices and the results were acceptable.

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