(129 days)
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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MAY - 8, 1997
Attachment 7 REVISED 510(K) SUMMARY
K96 5224
Summary of Safety and Effectiveness
Thorocolumbar Spinal System
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.
Testing of the Thorocolumbar Spinal System included comparison to substantially equivalent devices. The testing results were acceptable and the components should perform as well as comparable systems in clinical usage.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.